A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants

A Phase 1 Study to Evaluate the Pharmacokinetic Profile of ACH-0144471 Following Administration of Modified Release Prototype Formulations in Healthy Subjects

The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.

Inclusion Criteria:

• Body mass index of 18.0 to 30.0 kilograms/square meter.
• Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception.
• Male participants must either agree to abstinence or use of a condom plus an effective method of contraception.

Exclusion Criteria:

• Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months.
• History of any drug or alcohol abuse in the past 2 years; current tobacco/nicotine user or within the last 12 months; positive drugs of abuse test result.
• Clinically significant laboratory abnormalities.
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder.
• History or family history of meningococcal infection.
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• Presence or history of clinically significant allergy requiring treatment.
• Donation or loss of greater than 400 milliliters of blood within the previous 3 months.

Note: Other inclusion/exclusion criteria may apply, per protocol.