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

Last updated: May 14, 2024
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Carbamazepine

Rosuvastatin

Metformin

Clinical Study ID

NCT06071442
D7841C00012
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

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

Exclusion

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 thestudy 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-containingproduct use within 3 months prior to first dosing).

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

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

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

Study Design

Total Participants: 60
Treatment Group(s): 5
Primary Treatment: Carbamazepine
Phase: 1
Study Start date:
January 17, 2024
Estimated Completion Date:
April 12, 2024

Study 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.

Connect with a study center

  • Research Site

    Glendale, California 91206
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21225
    United States

    Site Not Available

  • Research Site

    Brooklyn, Maryland 21225
    United States

    Site Not Available

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