A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age - Trial NCT06354257
Access comprehensive clinical trial information for NCT06354257 through Pure Global AI's free database. This Phase 1 trial is sponsored by GlaxoSmithKline and is currently Recruiting. The study focuses on Tuberculosis. Target enrollment is 25 participants.
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Study Focus
Sponsor & Location
GlaxoSmithKline
Timeline & Enrollment
Phase 1
Apr 05, 2024
Oct 30, 2024
Primary Outcome
Area under the plasma drug concentration (AUC)-time curve from time zero to extrapolated to infinity (AUC[0-inf]) of EE after being administered with 14 days of GSK3036656 at DL 2,Maximum observed concentration (Cmax) of EE after being administered with 14 days of GSK3036656 at DL 2,AUC(0-inf) of LNG after being administered with 14 days of GSK3036656 at DL 2,Cmax of LNG after being administered with 14 days of GSK3036656 at DL 2
Summary
The purpose of this study is to provide data showing if there are any effects of GSK3036656
 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG),
 which will help inform future studies on suitable contraceptive measures to be used.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06354257
Non-Device Trial

