NCT06071442

Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine

A Three-Part Phase 1 Study to Evaluate the Potential Drug-Drug Interactions Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel-Ethinyl Estradiol-Containing Oral Contraceptives, and Carbamazepine in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the potential drug interactions between vemircopan and metformin, rosuvastatin, levonorgestrel/ ethinyl estradiol (LNG/EE)-containing oral contraceptive(s) (OCs), and carbamazepine in healthy participants.

Detailed description

This a 3-part drug-drug interaction (DDI) study. Part 1 - Potential Drug-drug Interaction Between Vemircopan, Metformin, and Rosuvastatin, Part 2 - Potential Drug-drug Interaction Between Vemircopan and LNG/EE-Containing OCs (Female Participants Only) Part 3 - Potential Drug-drug Interaction Between Vemircopan and Carbamazepine All the 3 parts of the study includes: * Screening Period: 27 days (Day -28 through Day -2) * Two Treatment Periods: * Part 1: Treatment Period 1 (Day -1 through Day 8) and Treatment Period 2 (Day 1 through Day 12) * Part 2: Treatment Period 1 (Day -1 through Day 7) and Treatment Period 2 (Day 1 through Day 10) * Part 3: Treatment Period 1 (Day -1 through Day 4) and Treatment Period 2 (Day 1 through Day 22) * Follow-up/Early Discontinuation Visit: 7 (± 2) days following the last dose of study intervention Up to 20 participants will be enrolled per study part. Participants will be enrolled in only one study part and will not be allowed to participate in more than 1 study part.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Vemircopan	Participants will receive oral tablets of Vemircopan.
DRUG	Rosuvastatin	Participants will receive oral coated tablets of Rosuvastatin.
DRUG	Metformin	Participants will receive oral film-coated tablets of Metformin.
DRUG	Levonorgestrel / Ethinyl Estradiol	Participants will receive oral tablets of Levonorgestrel/ Ethinyl Estradiol.
DRUG	Carbamazepine	Participants will receive oral chewable tablets of Carbamazepine.

Timeline

• Start date: 2024-01-17
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2023-10-06
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study