A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults

• Status: Completed
• Trial end date: 2018-10-17
• Target enrollment: 0
• Participant gender: All

Summary

This was a 3-part study with each part being an open-label, fixed-sequence, 2-period study in healthy adult participants.

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

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Collaborator: Achillion, a wholly owned subsidiary of Alexion
• Treatments: Aluminum hydroxide, magnesium hydroxide, drug combination; Antacids; Anti-Ulcer Agents; Calcium Carbonate; Cyclosporine; Cyclosporins; Magnesium Hydroxide; Omeprazole; Simethicone; Tacrolimus

Criteria

Key Inclusion Criteria:

• Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.

• Female participants must have been of non-childbearing potential and not needing to employ a method of contraception.

• Non-sterile male participants must have agreed to abstinence or used a highly effective method of contraception.

• No clinically significant history or presence of electrocardiogram findings at Screening and Day -1 of Period 1.

Key Exclusion Criteria:

• Evidence of any clinically significant deviation from normal in clinical laboratory evaluations.

• History of any medical or psychiatric condition or disease that might have limited the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.

• History or presence of drug or alcohol abuse within 2 years prior to first dosing; current tobacco/nicotine users and smokers; positive drugs-of-abuse and/or alcohol screen at Screening or Day -1 of Period 1.

• Any previous procedure that could have altered absorption or excretion of orally administered drugs.

• A history of significant multiple and/or severe allergies or had had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.

• Body temperature ≥ 38°Celsius at Screening, on Day -1, or Day 1 prior to first dosing; history of febrile illness, or other evidence of infection, within 14 days prior to first dosing.

• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever was longer.

• Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing; receipt of blood products within 6 months prior to first dosing.

• Part 3 Only: Genotyped as poor metabolizer of cytochrome P450 2C19.