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NCT06354257

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

A Phase 1, Open-label, Fixed Sequence, 1-way Drug-drug Interaction Study to Investigate the Pharmacokinetics of GSK3036656 and an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel When the Oral Contraceptive is Administered Alone and in Combination With GSK3036656 in Healthy Female Participants of Nonchildbearing Potential Aged 18-65 Years of Age
GlaxoSmithKline·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Tuberculosis
Drug/Device/Intervention
EE/LNG
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
Madrid, Spain
Timeline & enrollment
Phase
Phase 1
Start date
Apr 05, 2024
End date
Oct 30, 2024
Enrollment
25 participants
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
TuberculosisLatent tuberculosisTuberculosis of other organsCongenital tuberculosisSequelae of tuberculosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06354257
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.