Positive drugs of abuse screen at screening or Day -1 of Period 1. On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Talk with your doctor and family members or friends about deciding to join a study. For general information, Learn About Clinical Studies. Therapeutic FD inhibition was designed to control IVH and prevent C3-mediated extravascular hemolysis (EVH). The Company completed enrollment in the danicopan Phase 2 clinical trials for C3 glomerulopathy (C3G) and C3G/immune complex-mediated membrane glomerulonephritis (IC-MPGN). Our plan is to advance ACH-5228 into Phase 2 clinical trials in multiple diseases. History of procedures that could alter absorption or excretion of orally administered drugs. For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions. Participants will receive each treatment once, according to the randomization schedule. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 2 Names and Identifiers Expand this section. No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms). Read our, ClinicalTrials.gov Identifier: NCT04609696, Interventional Thus, danicopan can control both IVH and EVH therefore, making FD a promising target. Period 2: Danicopan as the PIC 2 formulation under fed conditions. Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception .  (Clinical Trial), A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of Danicopan After Administration as an Oral Tablet in the Fed and Fasted States in Participants of Japanese Descent. The decision from the EMA was based on danicopan safety and efficacy data from the Phase 2 PNH combination trial. You have reached the maximum number of saved studies (100). This trial was approved by regulatory agencies/local ethics committees and conducted according to International Conference on Harmonisation and Good Clinical Practice Standards. Celerion. Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee. Danicopan (ACH-4471) Phase 2 Add-on Trial with Eculizumab Danicopan was evaluated as an add-on with eculizumab, an intravenous C5 inhibitor that … Contents. Period 3: Danicopan as the PIC 1 formulation under fed conditions. Keywords provided by Alexion Pharmaceuticals: Why Should I Register and Submit Results? Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Number Of Participants With Treatment-Emergent Adverse Events [ Time Frame: Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose) ], Area Under The Concentration Versus Time Curve (AUC) Of Danicopan In Both Fed And Fasted States [ Time Frame: up to 72 hours postdose ], Maximum Observed Concentration (Cmax) Of Danicopan In Both Fed And Fasted States [ Time Frame: up to 72 hours postdose ], Time To Maximum Observed Concentration (Tmax) Of Danicopan In Both Fed And Fasted States [ Time Frame: up to 72 hours postdose ], Dose Proportionality Of Danicopan In Fed State Assessed by AUC [ Time Frame: up to 72 hours postdose ], Dose Proportionality Of Danicopan In Fed State Assessed by Cmax [ Time Frame: up to 72 hours postdose ], Activity Of Danicopan As Measured By Alternative Pathway Wieslab Assay [ Time Frame: up to 72 hours postdose ], Complement Factor B Fraction b Levels [ Time Frame: up to 72 hours postdose ], First generation (born to 2 Japanese parents and 4 Japanese grandparents), Born in Japan, and not have lived outside Japan for greater than 10 years, Lifestyle, including diet, must not have significantly changed since leaving Japan. History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study. The register also displays information on 18700 older paediatric trials (in scope of Article … Keywords provided by Alexion Pharmaceuticals: Why Should I Register and Submit Results? Fed participants will receive a single dose of 200 mg danicopan. This leads to inhibition of C3 cleavage, C3 fragment deposition, terminal pathway activation and MAC formation. In this open-label, phase 2, dose-finding trial, 10 untreated hemolytic PNH patients received danicopan monotherapy (100-200 mg thrice daily). More Information. Experimental: Part 2. Information provided by (Responsible Party): This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants. Scheduled pharmacokinetics (PK) and pharmacodynamics samples were collected, with a washout period of at least 14 days between the dose of warfarin in Period 1 and the first dose of danicopan in Period 2. Period 2: Participants received danicopan three times daily, in addition to coadministration with a single dose of warfarin. In this clinical trial, danicopan was generally well tolerated. Healthy, elderly, male participants will receive a single dose of danicopan under fed conditions. clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. For general information, Learn About Clinical Studies. “Danicopan, with its demonstrated ability to limit both intravascular and extravascular hemolysis with oral administration, has the potential to benefit … History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study. The EU Clinical Trials Register currently displays 39231 clinical trials with a EudraCT protocol, of which 6427 are clinical trials conducted with subjects less than 18 years old. On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Danicopan is under investigation in clinical trial NCT03459443 (A Proof of Concept Study for a 12 Month Treatment in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)). Period 1: Danicopan as a tablet under fed conditions. DrugBank. Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than 140/90 mmHg at screening. Period 3: Danicopan as the PIC 1 formulation under fasted conditions. No clinically significant history or presence of electrocardiogram findings as judged by the Investigator at screening and prior to the first dose of study intervention in Period 1. danicopan in patients with hemolytic PNH not receiving complement inhibitor treatment. Choosing to participate in a study is an important personal decision. Interim data was reported at … Alexion Pharmaceuticals. The relative bioavailability of the PIC 1 formulation versus the tablet formulation will be measured by the ratio of select pharmacokinetic (PK) parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time of administration to the last measurable concentration (AUC0-t), and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf). Current tobacco users and smokers or a positive cotinine test at screening. You have reached the maximum number of saved studies (100). Receipt of a vaccine within 30 days prior to the first dose of study intervention. This study was conducted to assess the 2-way interaction between danicopan and warfarin (Part 1), bupropion (Part 2), and ethinyl estradiol/norethindrone (EE/NET) as an oral contraceptive (Part 3). To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The top-line 24-week results from this combination trial was accepted for poster presentation at the 61 st American Society of Hematology (ASH) Annual Meeting scheduled for December 9 th in Orlando, FL. Please remove one or more studies before adding more. Blood samples will be collected for measurement of complement factor B fraction b levels. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Safety will be assessed throughout the study. Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 1 formulation under fed conditions. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection. Period 1: Danicopan as the PIC 1 formulation under fed conditions. History or presence of drug or alcohol abuse within previous 2 years, current tobacco user, or positive drugs-of-abuse screen or alcohol screen at screening or Day -1 of Period 1. Danicopan (ACH-4471), a selective and orally active small-molecule factor D inhibitor, shows high binding affinity to human Factor D with Kd value of 0.54 nM. Any major surgery within 4 weeks of the first dose of study intervention. More importantly, the trial has the potential to generate robust data to demonstrate the efficacy and safety of add-on, oral danicopan to C5 inhibitor therapy in PNH patients with clinically evident hemolysis. Period 1: Danicopan as the PIC 2 formulation under fasted conditions. Period 1: Danicopan as the PIC 2 formulation under fed conditions. Receipt of blood products within 6 months prior to the first dose of study intervention. Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention. Danicopan, our first-generation alternative pathway inhibitor, validated factor D as a target and we plan to begin a Phase 3 registrational study in early 2020,” said Joe Truitt, Chief Executive Officer of Achillion Pharmaceuticals. Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males [ Time Frame: Up to 72 hours postdose ] ... Clinical Trial Site: Tempe, Arizona, United States, 85283 : Sponsors and Collaborators. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609696. Danicopan (ACH-4471) inhibits alternative pathway of complement (APC) activity, has potential to block the alternative pathway of complement in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Is a female with a positive pregnancy test or who is lactating. In this clinical trial, danicopan was generally well tolerated. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Interim data was reported at the New Era of Aplastic Anemia and PNH Meeting in May 2019. Positive results for alcohol screen at screening or Day -1 of Period 1. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Choosing to participate in a study is an important personal decision. A total of 32 patients have been enrolled in the two trials; 13 C3G patients in the 6-month double-blind, placebo-controlled trial and 19 C3G/IC-MPGN patients in the 12-month single-arm open-label trial. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Period 2: Danicopan as the PIC 1 formulation under fed conditions. Clinical Trials Nct Page Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH) (ALPHA) Diagnosis or history of Gilbert's syndrome, in the opinion of the Investigator or designee. There will be a washout period of at least 5 days between each danicopan dosing. History or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds or commonly used antibacterial agents. Achillion, Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. Period 2: Danicopan as the PIC 2 formulation under fasted conditions. Period 3: Danicopan as the PIC 2 formulation under fasted conditions.  (Clinical Trial), A 2-Part, Open-Label, Randomized, Single-Dose, 3-Period Crossover, Phase 1, Relative Bioavailability, and Food Effect Study, Comparing Different Formulations of Danicopan in Healthy Adult Subjects. The FDA’s decision was based on positive safety and efficacy data from the ongoing danicopan Phase 2 PNH combination trial. Period 3: Danicopan as the PIC 2 formulation under fed conditions. Period 3: Danicopan as a tablet under fed conditions. History of febrile illness, or other evidence of infection, within 14 days prior to the first dose of study intervention. Fed participants will receive a single dose of 400 mg danicopan. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection. Participants who are of Japanese descent defined as: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The top line data from this … Danicopan is a first-in-class oral proximal, complement alternative pathway factor D (FD) inhibitor. Read our, ClinicalTrials.gov Identifier: NCT04451434, Interventional Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer. 3 Chemical and Physical Properties Expand this section. Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer. Danicopan - Achillion Pharmaceuticals Alternative Names: 4471; ACH-0144471; ACH-4471; ACH-CFDIS; ALXN 2040 ... 18 Sep 2020 Phase-III clinical trials in Paroxysmal nocturnal haemoglobinuria (Adjunctive treatment, In adults, In the elderly) in United Kingdom (PO) (EudraCT2019-003829-18) Subscriber content You need to be a logged in subscriber to view this content. Period 1: Danicopan as a tablet under fed conditions. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, receipt of blood products within 6 months prior to first dosing, or receipt of a vaccine within 30 days prior to first dosing. 1 Structures Expand this section. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Period 1: Danicopan as the PIC 1 formulation under fasted conditions. The EU Clinical Trials Register currently displays 39241 clinical trials with a EudraCT protocol, of which 6427 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article … There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2. This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent. Clinical Trials; Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH) Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH) Clinical Trial: NCT04469465. The FDA’s decision was based on positive safety and efficacy data from the ongoing danicopan Phase 2 PNH combination trial. Listing a study does not mean it has been evaluated by the U.S. Federal Government. There will be a washout period of at least 5 days between each danicopan dosing. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451434. Is a female with a positive pregnancy test at screening or Day -1 of Period 1 or who is lactating, or who plan to become pregnant (within 5 months of screening). Information provided by (Responsible Party): This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent. Study Design . Period 2: Danicopan administered under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Fasting participants will receive a single dose of 200 mg danicopan. The relative bioavailability of the PIC 2 formulation versus the tablet formulation will be measured by the ratio of select PK parameters: Cmax, AUC0-t, and AUC0-inf. Please remove one or more studies before adding more. Their corporate focus includes clinical trials for danicopan as a therapeutic drug for Complement 3 Glomerulopathy , which is one of the 95% of rare diseases without any approved therapy or drug. Danicopan is under investigation in clinical trial NCT03459443 (A Proof of Concept Study for a 12 Month Treatment in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)). Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening. Blood samples will be collected for measurement of danicopan activity. Unable to refrain from or anticipates the use of any drug. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation [ Time Frame: Up to 72 hours postdose ], AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions [ Time Frame: Up to 72 hours postdose ], AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions [ Time Frame: Up to 72 hours postdose ], Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions [ Time Frame: Up to 72 hours postdose ], Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions [ Time Frame: Up to 72 hours postdose ], Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation [ Time Frame: Up to 72 hours postdose ], AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions [ Time Frame: Up to 72 hours postdose ], AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions [ Time Frame: Up to 72 hours postdose ], Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions [ Time Frame: Up to 72 hours postdose ], Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions [ Time Frame: Up to 72 hours postdose ], Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions [ Time Frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1) ], Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions [ Time Frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1) ], Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions [ Time Frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1) ], Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions [ Time Frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1) ]. This Phase 3, pivotal trial will be the largest clinical evaluation of danicopan to date. Body temperature ≥ 38.0°Celcius at screening or prior to first dosing or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing. Participants who test positive for human immunodeficiency virus, hepatitis B virus, and/or hepatitis C virus. This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent. History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs. By inhibiting FD, oral danicopan blocks C3 convertase formation, the control point for AP activation and amplification of all pathways. There will be a washout period of at least 7 days between each dose of study intervention. In this clinical trial, danicopan was generally well tolerated. The decision from the EMA was based on danicopan safety and efficacy data from the Phase 2 PNH combination trial. Danicopan (200 milligrams) will be administered orally on Day 1. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as a tablet under fed conditions. Period 2: Danicopan as a tablet under fed conditions. Danicopan, our first-generation alternative pathway inhibitor, validated factor … Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meters squared, inclusive, with a minimum body weight of 50.0 kg at screening. Talk with your doctor and family members or friends about deciding to join a study. – 2.4 g/dL mean increase in hemoglobin at 24 weeks –– Reduction in blood transfusions from 34 to 1; and improvements in markers of hemolysis –- Completed End... | February 17, 2021 Our plan is to advance ACH-5228 into Phase 2 clinical trials in multiple diseases. Period 3: Danicopan as a tablet under fed conditions. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Enten Füttern Corona, Lecker An Bord Rezepte Gulasch, Brief An Zukünftige Patentante, Ikea Malm Kommode 6 Schubladen Spiegel, Tanklinierung Selber Machen, Youtube Trends Usa, Reifen Richtig Billig Gutschein, Weibliche Form Von Malheureux, Dupilumab Neurodermitis Erfahrungen,