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

• Status: Completed
• Trial end date: 2018-03-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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.