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Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

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NCT07792408 · readout in 194 d

Sponsored by Vertex Pharmaceuticals Incorporated (industry) · VRTX — their whole pipeline →.

Phase
Phase 1
Status
Not yet recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
148estimated

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 2026-08-28

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2026-08-28estimatedWhen the study began enrolling
Primary completion2027-03-11estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-03-20estimatedThe whole study's end, after follow-up
First posted2026-08-28actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-28actualThe 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 OF
Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/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): Maximum Observed Plasma Concentration (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 C (Optional): Maximum Observed Plasma Concentration (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 D (Optional): Maximum Observed Plasma Concentration (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 A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG/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): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) 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 C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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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