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

A Phase 1 Study To Determine The Relative Bioavailability Of ACH-0144471 After Administration Of A Tablet Or Softgel Capsule Versus A Liquid Filled Capsule In Healthy Volunteers

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.

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.