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

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Vemircopan; Drug: Levonorgestrel / Ethinyl Estradiol; Drug: Carbamazepine; Drug: Rosuvastatin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06071442

D7841C00012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Part 1: Vemircopan, Metformin and Rosuvastatin

Experimental group

Description:

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.

Treatment:

Drug: Rosuvastatin

Drug: Metformin

Drug: Vemircopan

Part 2: Vemircopan and LNG/EE-Containing OCs

Experimental group

Description:

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.

Treatment:

Drug: Levonorgestrel / Ethinyl Estradiol

Drug: Vemircopan

Part 3: Vemircopan and Carbamazepine

Experimental group

Description:

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.

Treatment:

Drug: Carbamazepine

Drug: Vemircopan