Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
← catalyst calendarSponsored by Vertex Pharmaceuticals Incorporated (industry) · VRTX — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
74actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-11 | actual | When the study began enrolling |
| Primary completion | 2026-02-20 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-27 | actual | The whole study's end, after follow-up |
| First posted | 2025-07-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Interventions
- Drug: VX-407
- Drug: LNG/EE
- Drug: NGM/EE
- Drug: NET/EE
- Drug: DRSP/EE
Primary outcomes
what the primary-completion date above is the date OFPart A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407
measured From Day 1 up to Day 7 and Day 21 up to Day 27
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
measured From Day 1 up to Day 7 and Day 21 up to Day 27
Part B (Optional): Cmax of Norelgestromin (NGMN) and Norgestrel (NG) (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407
measured From Day 1 up to Day 9 and Day 23 up to Day 31
Part B (Optional): AUC0-inf of NGMN and NG (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407
measured From Day 1 up to Day 9 and Day 23 up to Day 31
Part C (Optional): Cmax of NET and EE in the Absence and Presence of VX-407
measured From Day 1 up to Day 5 and Day 19 up to Day 23
Part C (Optional): AUC0-inf of NET and EE in the Absence and Presence of VX-407
measured From Day 1 up to Day 5 and Day 19 up to Day 23
Part D (Optional): Cmax of DRSP and EE in the Absence and Presence of VX-407
measured From Day 1 up to Day 7 and Day 21 up to Day 27
Part D (Optional): AUC0-inf of DRSP and EE in the Absence and Presence of VX-407
measured From Day 1 up to Day 7 and Day 21 up to Day 27
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