A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and… (NCT06354257) | Clinical Trial Compass
CompletedPhase 1
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
Spain20 participantsStarted 2024-04-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Participant was 18 to 65 years of age, inclusive, at the time of signing the informed consent.
✓. Participants were healthy or compensated, as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
✓. Creatinine clearance was \>= 75 mL/min.
✓. Echocardiogram was normal or showed normal left ventricular function; at most trace to mild valvular regurgitation was allowed, with no valvular stenosis.
✓. Body weight was \>= 45.0 kg (99 lbs), and body mass index was within the range 18.5 to 31.0 kg/m² (inclusive).
✓. Female participants were of Nonchildbearing Potential (WONCBP).
✓. Documented hysterectomy.
✓. Documented bilateral salpingectomy.
Exclusion criteria
✕. History of known cardiac valve abnormalities.
✕. Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study treatment.
✕. Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study treatment, and positive on reflex to hepatitis C RNA.
✕. Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.
What they're measuring
1
Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG
Timeframe: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
2
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG
Timeframe: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
✕. Alanine aminotransferase (ALT) \> 1.5×ULN. A single repeat of ALT was allowed within a single screening period to determine eligibility.
✕. Bilirubin \> 1.5×ULN (isolated bilirubin \> 1.5×ULN was acceptable if bilirubin was fractionated and direct bilirubin was \< 35%).
✕. Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should have precluded participation in the study of an investigational compound.