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

Study Identifier:
D7841C00012
ClinicalTrials.gov Identifier:
NCT06071442
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Vemircopan
  • Drug: Rosuvastatin
  • Drug: Metformin
  • Drug: Levonorgestrel / Ethinyl Estradiol
  • Drug: Carbamazepine
Date
Jan 2024 - Apr 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion 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.
Sex
Female & Male
Age
18 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Vemircopan
  • Drug: Rosuvastatin
  • Drug: Metformin
  • Drug: Levonorgestrel / Ethinyl Estradiol
  • Drug: Carbamazepine
Date
Jan 2024 - Apr 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years years
Requirements Information
Inclusion and Exclusion 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.

Protocol 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.

Trial Locations

Location
Status
Location
Research Site
Brooklyn, Maryland, United States, 21225
Status
N/A