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

NCT ID: NCT06071442

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2024-04-12

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Vemircopan, Metformin and Rosuvastatin

Participants will receive Vemircopan, Metformin and Rosuvastatin in a fixed sequence over 2 periods.

Period 1 (8 days): Participants will receive a single dose of metformin on day 1 and a single dose of rosuvastatin on day 4.

Period 2 (12 days): Participants will receive vemircopan twice daily from day 1 to day 11. On day 5, participants will receive metformin co-administered with vemircopan. On day 8, participants will receive rosuvastatin co-administered with vemircopan.

There will be a washout period of at least 4 days between the dose of rosuvastatin in Period 1 and the first dose of vemircopan in Period 2.

Group Type: EXPERIMENTAL

Vemircopan

Intervention Type: DRUG

Participants will receive oral tablets of Vemircopan.

Rosuvastatin

Intervention Type: DRUG

Participants will receive oral coated tablets of Rosuvastatin.

Metformin

Intervention Type: DRUG

Participants will receive oral film-coated tablets of Metformin.

Part 2: Vemircopan and LNG/EE-Containing OCs

Participants will receive Vemircopan and LNG/EE-Containing OCs in a fixed sequence over 2 periods.

Period 1 (7 days): Participants will receive a single dose of OC, consisting of LNG and EE on day 1.

Period 2 (10 days): Participants will receive multiple doses of vemircopan from day 1 to day 9. On day 5, participants will receive a single dose of OC co-administered with vemircopan.

There will be a washout period of at least 7 days between the dose of OC in Period 1 and the first dose of vemircopan in Period 2.

Group Type: EXPERIMENTAL

Vemircopan

Intervention Type: DRUG

Participants will receive oral tablets of Vemircopan.

Levonorgestrel / Ethinyl Estradiol

Intervention Type: DRUG

Participants will receive oral tablets of Levonorgestrel/ Ethinyl Estradiol.

Part 3: Vemircopan and Carbamazepine

Participants will receive Vemircopan and Carbemazepine in a fixed sequence over 2 periods.

Period 1 (4 days): Participants will receive a single oral dose of vemircopan on day 1.

Period 2 (22 days): Participants will receive carbemazepine twice daily from day 1 to day 21. On day 19, participants will receive a single oral dose of vemircopan co-administered with carbamazepine.

There will be a washout period of at least 4 days between the dose of vemircopan in Period 1 and the first dose of carbamazepine in Period 2.

Group Type: EXPERIMENTAL

Vemircopan

Intervention Type: DRUG

Participants will receive oral tablets of Vemircopan.

Carbamazepine

Intervention Type: DRUG

Participants will receive oral chewable tablets of Carbamazepine.

Interventions

Vemircopan

Participants will receive oral tablets of Vemircopan.

Intervention Type: DRUG

Rosuvastatin

Participants will receive oral coated tablets of Rosuvastatin.

Intervention Type: DRUG

Metformin

Participants will receive oral film-coated tablets of Metformin.

Intervention Type: DRUG

Levonorgestrel / Ethinyl Estradiol

Participants will receive oral tablets of Levonorgestrel/ Ethinyl Estradiol.

Intervention Type: DRUG

Carbamazepine

Participants will receive oral chewable tablets of Carbamazepine.

Intervention Type: DRUG

Other Intervention Names

ALXN2050; SIMPESSE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Brooklyn, Maryland, United States

Countries

United States

Other Identifiers

ALXN2050-HV-111

Identifier Type: OTHER

Identifier Source: secondary_id

D7841C00012

Identifier Type: -

Identifier Source: org_study_id