Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants

• Status: Completed
• Trial end date: 2016-10-05
• Target enrollment: 0
• Participant gender: All

Summary

This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Collaborator: Achillion, a wholly owned subsidiary of Alexion

Criteria

Key Inclusion Criteria:

• Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.

• Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.

Key Exclusion Criteria:

• History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.

• History of procedures that could alter absorption of orally administered drugs.

• Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.

• Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.

• Participation in a clinical study within 30 days prior to study drug administration.

• Clinically significant laboratory abnormalities at Screening or Day -1.