Status:
COMPLETED
Study of Danicopan in Participants of Japanese Descent
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent. On Day 1 of each period, participants will receive a single oral dose o...
Eligibility Criteria
Inclusion
- Participants who are of Japanese descent defined as:
- 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
- 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.
- 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.
Exclusion
- Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee.
- 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.
- History or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds or commonly used antibacterial agents.
- History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
- History of febrile illness, or other evidence of infection, within 14 days prior to the first dose of study intervention.
- Any major surgery within 4 weeks of the first dose of study intervention.
- Diagnosis or history of Gilbert's syndrome, in the opinion of the Investigator or designee.
- Unable to refrain from or anticipates the use of any drug.
- Receipt of a vaccine within 30 days prior to the first dose of study intervention.
- Receipt of blood products within 6 months prior to the first dose of study intervention.
- 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.
- Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than 140/90 mmHg at screening.
- Participants who test positive for human immunodeficiency virus, hepatitis B virus, and/or hepatitis C virus.
- Current tobacco users and smokers or a positive cotinine test at screening.
- 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.
- Positive drugs of abuse screen at screening or Day -1 of Period 1.
- Positive results for alcohol screen at screening or Day -1 of Period 1.
- 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).
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04451434
Start Date
August 17 2020
End Date
September 28 2020
Last Update
February 15 2021
Active Locations (1)
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1
Clinical Study Site
Brisbane, Australia