A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants

• Status: Completed
• Trial end date: 2017-06-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants.

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

Details

• Lead Sponsor: Achillion Pharmaceuticals; Alexion Pharmaceuticals
• Collaborator: Achillion, a wholly owned subsidiary of Alexion
• Treatments: Fexofenadine; Midazolam; Mycophenolate mofetil; Mycophenolic Acid; Terfenadine

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.

• Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.

Key Exclusion Criteria:

• Mentally or legally incapacitated or significant emotional problems.

• Any condition that might interfere with drug absorption.

• History of sensitivity to study medication or other drug allergies.

• Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.

• Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration.

• Participated in another clinical study within 28 days prior to the first dose.

• Significant laboratory abnormalities.

• Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.