Phase 1, Open-label Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Subjects
Abstract
The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE, norethindrone (NET) and EE and drospirenone (DRSP) and EE. Also, to evaluate the safety and tolerability of co-administration of VX-407 with LNG/EE, NGM/EE, NET/EE and DRSP/EE.
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Primary outcome: Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407; Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG and EE in the Absence and Presence of VX-407; Part B (Optional): Cmax of Norelgestromin (NGMN) and Norgestrel (NG) (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407; Part B (Optional): AUC0-inf of NGMN and NG (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407; Part C (Optional): Cmax of NET and EE in the Absence and Presence of VX-407; Part C (Optional): AUC0-inf of NET and EE in the Absence and Presence of VX-407; Part D (Optional): Cmax of DRSP and EE in the Absence and Presence of VX-407; Part D (Optional): AUC0-inf of DRSP and EE in the Absence and Presence of VX-407.
Enrollment: 74 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 74 participants or records.
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