Status:
COMPLETED
Study of a Single Dose of Danicopan in Healthy Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Achillion, a wholly owned subsidiary of Alexion
Conditions:
Healthy
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief Summary
This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (...
Eligibility Criteria
Inclusion
- Healthy defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
Exclusion
- History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Any condition possibly affecting drug absorption (for example, gastrectomy), cholecystectomy to be considered acceptable.
- Body temperature ≥ 38°Celcius on Day -1 or Day 1 Hour 0; history of febrile illness or other evidence of infection within 14 days prior to study drug administration.
- Current tobacco/nicotine users; consumption of any alcohol within 72 hours before study drug administration or a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of Screening; positive urine drug screen at Screening or Day -1.
- Clinically significant laboratory abnormalities at either Screening or Day -1.
Key Trial Info
Start Date :
February 4 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04889677
Start Date
February 4 2016
End Date
June 21 2016
Last Update
May 17 2021
Active Locations (1)
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1
Clinical Trial Site
Auckland, New Zealand