Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT06071442
- Run by
- Alexion Pharmaceuticals, Inc.
- People needed
- 60
- Starts
- 2024-01-17
- Expected to finish
- 2024-04-12
- Last updated by the study team
- 2025-08-12
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Research Site — Brooklyn, Maryland, United States
Full record on ClinicalTrials.gov
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