NCT04709094

A Drug Interaction Study of Danicopan

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This was a 3-part study (Part 1, Part 2, Part 3) with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.

Detailed description

This study was conducted to assess the 2-way interaction between danicopan and warfarin (Part 1), bupropion (Part 2), and ethinyl estradiol/norethindrone (EE/NET) as an oral contraceptive (Part 3).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Danicopan	Danicopan was dosed as 2 x 100 milligram (mg) tablets.
DRUG	Warfarin	Warfarin was dosed as 2 x 10 mg and 1 x 5 mg warfarin sodium tablets (Coumadin or generic equivalent).
DRUG	Bupropion	Bupropion was dosed as Wellbutrin (or generic equivalent) as 1 x 100 mg tablet.
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.

Timeline

• Start date: 2019-07-28
• Primary completion: 2019-10-14
• Completion: 2020-04-17
• First posted: 2021-01-14
• Last updated: 2021-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study