Status:
COMPLETED
Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 carba...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06071442
Start Date
January 17 2024
End Date
April 12 2024
Last Update
August 12 2025
Active Locations (1)
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1
Research Site
Brooklyn, Maryland, United States, 21225