Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02159131 | Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects | PHASE1 | COMPLETED | 20 | — | — | Aug 1, 2014 | Dec 1, 2014 | Jul 7, 2015 | 1 | United Kingdom |
Blood samples will be collected to estimate the area under the concentration-time curve over the dosing interval (AUC\[0-tau\]) of LNG and EE following OC with and without 744
| Arm | Type | Description |
|---|---|---|
| OC containing levonorgestrel and ethinyl estradiol + GSK126574 | EXPERIMENTAL | Eligible subjects will enter a run-in-period of 21 days (may extend to 49 days) to stabilize on OC containing levonorgestrel and ethinyl estradiol in order to synchronize the menstrual cycles of multiple subjects. Subjects completing run-in-period will enter Treatment period 1 and will be dosed OC once daily on Days 1 to 10. At day 11 subjects will enter Treatment period 2 and will be dosed with OC containing levonorgestrel and ethinyl estradiol + 744 once daily on Day 12 to 19. Subjects completing Treatment period 2 will have 7 OC free days (Day 22 to 28) during which withdrawal menses should occur. Subjects will then be followed up for 7 to 14 days (Day 28 to 35/49). |
| Name | Type | Description |
|---|---|---|
| Ethinyl Estadiol | DRUG | EE is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water |
| Levonorgestrel | DRUG | LNG is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water |
| GSK1265744 | DRUG | GSK1265744 is available as 30 mg tablet to be taken along with 240 mL water |
Inclusion Criteria: * Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Females aged between 18 and 45 years of age inclusive, at the time of si...