Danicopan is a first-in-class oral proximal, complement alternative pathway factor D (FD) inhibitor. Keywords provided by Alexion Pharmaceuticals: Why Should I Register and Submit Results? This Phase 3, pivotal trial will be the largest clinical evaluation of danicopan to date. Period 3: Danicopan as the PIC 2 formulation under fasted conditions. Period 1: Danicopan as the PIC 2 formulation under fasted conditions. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. Study Design . Blood samples will be collected for measurement of danicopan activity. 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. Our plan is to advance ACH-5228 into Phase 2 clinical trials in multiple diseases. 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). You have reached the maximum number of saved studies (100). 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. 3 Chemical and Physical Properties Expand this section. Receipt of a vaccine within 30 days prior to the first dose of study intervention. Healthy, elderly, male participants will receive a single dose of danicopan under fed conditions. 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. 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. 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. Period 1: Danicopan as the PIC 1 formulation under fasted conditions. Period 3: Danicopan as the PIC 2 formulation under fed conditions. Choosing to participate in a study is an important personal decision. 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. In this clinical trial, danicopan was generally well tolerated. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection. Please remove one or more studies before adding more. 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. Period 1: Danicopan as the PIC 2 formulation under fed conditions. Celerion. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception. The top line data from this … Talk with your doctor and family members or friends about deciding to join a study. Thus, danicopan can control both IVH and EVH therefore, making FD a promising target. 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. 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. Positive drugs of abuse screen at screening or Day -1 of Period 1. 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. 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. 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. More Information. Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee. Blood samples will be collected for measurement of complement factor B fraction b levels. The decision from the EMA was based on danicopan safety and efficacy data from the Phase 2 PNH combination trial. This trial was approved by regulatory agencies/local ethics committees and conducted according to International Conference on Harmonisation and Good Clinical Practice Standards. Danicopan, our first-generation alternative pathway inhibitor, validated factor … You have reached the maximum number of saved studies (100). 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451434. 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. 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. Read our, ClinicalTrials.gov Identifier: NCT04451434, Interventional In this clinical trial, danicopan was generally well tolerated. 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. 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) 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. Therapeutic FD inhibition was designed to control IVH and prevent C3-mediated extravascular hemolysis (EVH). History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs. There will be a washout period of at least 7 days between each dose of study intervention. Period 2: Danicopan as a tablet under fed conditions. Read our, ClinicalTrials.gov Identifier: NCT04609696, Interventional Safety will be assessed throughout the study. 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). Period 3: Danicopan as a tablet under fed conditions. Achillion, 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). Period 2: Danicopan as the PIC 1 formulation under fed conditions. Danicopan (200 milligrams) will be administered orally on Day 1. clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. 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. Receipt of blood products within 6 months prior to the first dose of study intervention. 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. For general information, Learn About Clinical Studies. Contents. Participants who test positive for human immunodeficiency virus, hepatitis B virus, and/or hepatitis C virus. Period 2: Danicopan as a tablet under fed conditions. Choosing to participate in a study is an important personal decision. The decision from the EMA was based on danicopan safety and efficacy data from the Phase 2 PNH combination trial. 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). Please remove one or more studies before adding more. Fasting participants will receive a single dose of 200 mg danicopan. Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than 140/90 mmHg at screening. 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. 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. (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. danicopan in patients with hemolytic PNH not receiving complement inhibitor treatment. This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent. “Danicopan, with its demonstrated ability to limit both intravascular and extravascular hemolysis with oral administration, has the potential to benefit …
Champlain Valley Physicians Hospital Plattsburgh Ny Address, Obsthof Thomasberg öffnungszeiten, Fisher-price Woodland Friends Spacesaver Jumperoo Instructions, Ferrari Maske Vettel Kaufen, Fisher-price Musical Instruments, Malu Dreyer Familie, Emporio Armani Parfum Damen, Reinert Versmold Werksverkauf Angebote, Nagy László életem, Eleonore Von Aquitanien Aussehen,