Study identifier:ACH471-017
ClinicalTrials.gov identifier:NCT04709094
EudraCT identifier:N/A
CTIS identifier:N/A
A Three-Part Phase 1 Study to Evaluate the Potential Drug Interaction between ACH-0144471 and Warfarin, Bupropion, and Ethinyl Estradiol and Norethindrone (Oral Contraceptive) in Healthy Adult Subjects
Healthy
Phase 1
Yes
Danicopan, Warfarin, Bupropion, Ethinyl Estradiol/Norethindrone
All
52
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science
Verified 01 Mar 2024 by Alexion Pharmaceuticals
Alexion Pharmaceuticals
Achillion, a wholly owned subsidiary of Alexion, Celerion
No locations available
Arms | Assigned Interventions |
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Experimental: Part 1: Danicopan and Warfarin Period 1: Participants received a single dose of warfarin. Period 2: Participants received danicopan three times daily, in addition to coadministration with a single dose of warfarin. Scheduled pharmacokinetics (PK) and pharmacodynamics samples were collected, with a washout period of at least 14 days between the dose of warfarin in Period 1 and the first dose of danicopan in Period 2. | Drug: Danicopan Danicopan was dosed as 2 x 100 milligram (mg) tablets. Other Name: ACH-0144471 Other Name: ALXN2040 Drug: Warfarin Warfarin was dosed as 2 x 10 mg and 1 x 5 mg warfarin sodium tablets (Coumadin or generic equivalent). Other Name: Coumadin |
Experimental: Part 2: Danicopan and Bupropion Period 1: Participants received a single dose of bupropion. Period 2: Participants received danicopan three times daily, in addition to coadministration with a single dose of bupropion. Scheduled PK samples were collected, with a washout period of at least 7 days between the dose of bupropion in Period 1 and the first dose of danicopan in Period 2. | Drug: Danicopan Danicopan was dosed as 2 x 100 milligram (mg) tablets. Other Name: ACH-0144471 Other Name: ALXN2040 Drug: Bupropion Bupropion was dosed as Wellbutrin (or generic equivalent) as 1 x 100 mg tablet. Other Name: Bupropion HCl Other Name: Wellbutrin |
Experimental: Part 3: Danicopan and EE/NET Period 1: Participants received a single dose of EE/NET. Period 2: Participants received danicopan three times daily, in addition to coadministration with a single dose of EE/NET. Scheduled PK samples were collected, with a washout period of at least 7 days between the dose of EE/NET in Period 1 and the first dose of danicopan in Period 2. | Drug: Danicopan Danicopan was dosed as 2 x 100 milligram (mg) tablets. Other Name: ACH-0144471 Other Name: ALXN2040 Drug: Ethinyl Estradiol/Norethindrone EE/NET (0.035 mg/1 mg) was dosed as Ortho-Novum-1/35 (or generic equivalent) fixed-dose combination tablets. Other Name: Ortho-Novum |