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

• Status: Completed
• Trial end date: 2024-04-12
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Alexion Pharmaceuticals, Inc.
• Treatments: Carbamazepine; Estradiol; Ethinyl Estradiol; Levonorgestrel; Metformin; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Participants who are medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.

• Body weight of at minimum 50 kg and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive) at the Screening.

• Male and female participants should adhere to the protocol defined contraceptive methods.

Exclusion Criteria:

• History or presence of medical (eg, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or other disorders) or psychiatric conditions or diseases.

• History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.

• History of drug or alcohol abuse within 2 years prior to first dosing

• Current tobacco users or smokers (defined as any tobacco or nicotine-containing product use within 3 months prior to first dosing).

• Donation of whole blood from 3 months prior to first dose administration, or of plasma from 30 days before first dose administration.

• Female participants who have a positive pregnancy test at Screening or Day -1, or who are lactating.

• Positive drugs of abuse, cotinine, or alcohol screen at Screening or Day -1.