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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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NCT06354257
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06354257
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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

Study Focus

Tuberculosis

EE/LNG

Interventional

drug

Sponsor & Location

GlaxoSmithKline

Madrid, Spain

Timeline & Enrollment

Phase 1

Apr 05, 2024

Oct 30, 2024

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

Tuberculosis
Latent tuberculosis
Tuberculosis of other organs
Congenital tuberculosis
Sequelae of tuberculosis

Data Source

ClinicalTrials.gov

NCT06354257

Non-Device Trial