A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults
NCT ID: NCT05109390
Last Updated: 2021-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2018-07-27
2018-10-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Part 1: Danicopan plus Cyclosporine
Participants (N=14) received danicopan and cyclosporine in a fixed sequence over 2 periods:
Treatment A (Period 1): 300 milligrams (mg) cyclosporine administered on Day 1.
Treatment B (Period 2): 200 mg danicopan administered 3 times daily (TID) on Days 1-7 with 300 mg cyclosporine coadministered on Day 5.
There was a washout period of 3 days between the dose of cyclosporine in Period 1 and the first dose of danicopan in Period 2.
Danicopan
Oral tablet.
Cyclosporine
Oral capsule.
Part 2: Danicopan plus Tacrolimus
Participants (N=28) received danicopan and tacrolimus in a fixed sequence over 2 periods:
Treatment C (Period 1): 2 mg tacrolimus administered on Day 1.
Treatment D (Period 2): 200 mg danicopan administered TID on Days 1-10 with 2 mg tacrolimus coadministered on Day 5.
There was a washout period of 7 days between the dose of tacrolimus in Period 1 and the first dose of danicopan in Period 2.
Danicopan
Oral tablet.
Tacrolimus
Oral capsule.
Part 3: Danicopan plus Antacids and Omeprazole
Participants (N=30) received danicopan, calcium carbonate, aluminum/magnesium hydroxide/simethicone, and omeprazole in fixed sequences over 2 periods:
Treatment E1 (Period 1): 200 mg danicopan administered TID on Days 1-4. Treatment E2 (Period 1): 200 mg danicopan coadministered with 1 gram calcium carbonate on Day 5.
Treatment F1 (Period 1): 200 mg danicopan administered TID on Days 1-4. Treatment F2 (Period 1): 200 mg danicopan coadministered with 200 mg aluminum hydroxide/200 magnesium hydroxide/25 mg simethicone on Day 5.
Note: Participants were randomized in a 1:1 ratio to receive either Treatment E2 or F2 coadministered with danicopan on Day 5.
Treatment G1 (Period 2): 40 mg omeprazole administered once daily (QD) on Days 1-4.
Treatment G2 (Period 2): 40 mg omeprazole administered QD with 200 mg danicopan administered orally TID on Days 5-8.
There was a washout period of 2 days between the last dose of danicopan in Period 1 and the first dose of omeprazole in Period 2.
Danicopan
Oral tablet.
Calcium Carbonate
Chewable tablet.
Aluminum/Magnesium Hydroxide/Simethicone
Chewable tablet.
Omeprazole
Oral, delayed-release capsule.
Interventions
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Danicopan
Oral tablet.
Cyclosporine
Oral capsule.
Tacrolimus
Oral capsule.
Calcium Carbonate
Chewable tablet.
Aluminum/Magnesium Hydroxide/Simethicone
Chewable tablet.
Omeprazole
Oral, delayed-release capsule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Achillion, a wholly owned subsidiary of Alexion
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Tempe, Arizona, United States
Countries
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Other Identifiers
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ACH471-014
Identifier Type: -
Identifier Source: org_study_id