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) ]. Fed participants will receive a single dose of 200 mg danicopan. Receipt of blood products within 6 months prior to the first dose of study intervention. – 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 Read our, ClinicalTrials.gov Identifier: NCT04609696, Interventional Period 2: Danicopan as the PIC 2 formulation under fed conditions. Talk with your doctor and family members or friends about deciding to join a study. Period 3: Danicopan as the PIC 2 formulation under fed conditions. Danicopan is a first-in-class oral proximal, complement alternative pathway factor D (FD) inhibitor. Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than 140/90 mmHg at screening. Choosing to participate in a study is an important personal decision. Period 1: Danicopan as the PIC 2 formulation under fasted conditions. 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). 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 3: Danicopan as the PIC 2 formulation under fasted conditions. 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.  (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. 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. 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. Alexion Pharmaceuticals. “Danicopan, with its demonstrated ability to limit both intravascular and extravascular hemolysis with oral administration, has the potential to benefit … History of meningococcal infection, or a first-degree relative with a history of meningococcal infection. 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. You have reached the maximum number of saved studies (100). Period 2: Danicopan as the PIC 1 formulation under fasted conditions. In this open-label, phase 2, dose-finding trial, 10 untreated hemolytic PNH patients received danicopan monotherapy (100-200 mg thrice daily). The FDA’s decision was based on positive safety and efficacy data from the ongoing danicopan Phase 2 PNH combination trial. Danicopan, our first-generation alternative pathway inhibitor, validated factor … 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 39241 clinical trials with a EudraCT protocol, of which 6427 are clinical trials conducted with subjects less than 18 years old. 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. Period 1: Danicopan as the PIC 2 formulation under fed conditions. Danicopan (200 milligrams) will be administered orally on Day 1. Read our, ClinicalTrials.gov Identifier: NCT04451434, Interventional For general information, Learn About Clinical Studies. 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. 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. Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee. The decision from the EMA was based on danicopan safety and efficacy data from the Phase 2 PNH combination trial. Period 2: Participants received danicopan three times daily, in addition to coadministration with a single dose of warfarin. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. 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. Thus, danicopan can control both IVH and EVH therefore, making FD a promising target. This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609696. 2 Names and Identifiers Expand this section. Is a female with a positive pregnancy test or who is lactating. 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). Contents. History of procedures that could alter absorption or excretion of orally administered drugs. 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. 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. clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. 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. There will be a washout period of at least 7 days between each dose of study intervention. For general information, Learn About Clinical Studies. This leads to inhibition of C3 cleavage, C3 fragment deposition, terminal pathway activation and MAC formation. No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms). 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). Study Design . The register also displays information on 18700 older paediatric trials (in scope of Article … 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. Fasting participants will receive a single dose of 200 mg danicopan. 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. Please remove one or more studies before adding more. The Company completed enrollment in the danicopan Phase 2 clinical trials for C3 glomerulopathy (C3G) and C3G/immune complex-mediated membrane glomerulonephritis (IC-MPGN). Fed participants will receive a single dose of 400 mg danicopan. 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. danicopan in patients with hemolytic PNH not receiving complement inhibitor treatment. 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. Period 1: Danicopan as a tablet under fed conditions. Positive results for alcohol screen at screening or Day -1 of Period 1. In this clinical trial, danicopan was generally well tolerated. Period 3: Danicopan as a tablet under fed 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. The register also displays information on 18700 older paediatric trials (in scope of Article … Interim data was reported at … This trial was approved by regulatory agencies/local ethics committees and conducted according to International Conference on Harmonisation and Good Clinical Practice Standards. You have reached the maximum number of saved studies (100). Positive drugs of abuse screen at screening or Day -1 of Period 1. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. There will be a washout period of at least 5 days between each danicopan dosing. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Participants who test positive for human immunodeficiency virus, hepatitis B virus, and/or hepatitis C virus. Therapeutic FD inhibition was designed to control IVH and prevent C3-mediated extravascular hemolysis (EVH). Period 2: Danicopan as a tablet under fed conditions. Talk with your doctor and family members or friends about deciding to join a study. Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception . Period 2: Danicopan administered under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fasted conditions. Healthy, elderly, male participants will receive a single dose of danicopan under fed conditions. By inhibiting FD, oral danicopan blocks C3 convertase formation, the control point for AP activation and amplification of all pathways. Period 1: Danicopan as a tablet under fed conditions. This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451434. Receipt of a vaccine within 30 days prior to the first dose of study intervention. Period 3: Danicopan as a tablet under fed conditions. 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. Participants will receive each treatment once, according to the randomization schedule. Period 1: 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. Danicopan (ACH-4471) Phase 2 Add-on Trial with Eculizumab Danicopan was evaluated as an add-on with eculizumab, an intravenous C5 inhibitor that … 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 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. History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs. The decision from the EMA was based on danicopan safety and efficacy data from the Phase 2 PNH combination trial. 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. Blood samples will be collected for measurement of danicopan activity. 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. This Phase 3, pivotal trial will be the largest clinical evaluation of danicopan to date. 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. 3 Chemical and Physical Properties Expand this section. 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. Period 3: Danicopan as the PIC 1 formulation under fed conditions. 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. The FDA’s decision was based on positive safety and efficacy data from the ongoing danicopan Phase 2 PNH combination trial.
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