At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Microgynon and GSK3036656 for Tuberculosis. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants received 1 dose of Microgynon (0.03 mg EE/0.15 mg LNG) on Day 1 of Treatment Period 1 and 1 dose co-administered with GSK3036656 20 mg on Day 15 of Treatment Period 3.
Participants received 1 loading dose of 40 mg on Day 4 and a dose of 20 mg on Days 5 to 14 once daily in Treatment Period 2. In Treatment Period 3, participants received one 20 mg dose along with Microgynon (0.03 mg EE/0.15 mg LNG) on Day 15 after which a 20 mg dose on Days 17 and 18 once daily.