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Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants

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NCT06820307

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

Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
50actual
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
DateFiledBasisWhat it is
Start2025-02-25actualWhen the study began enrolling
Primary completion2025-04-29actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-04-29actualThe whole study's end, after follow-up
First posted2025-02-11actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-05-29actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Pain

Interventions

  • Drug: Suzetrigine — also filed as VX-548, SUZ
  • Drug: DRSP/EE
  • Drug: NGM/EE

Primary outcomes

what the primary-completion date above is the date OF
Part A: Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of SUZ
measured Pre-dose up to Day 25 Post-dose
Part A: 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 SUZ
measured Pre-dose up to Day 25 Post-dose
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of DRSP and EE in the Absence and Presence of SUZ
measured Pre-dose up to Day 25 Post-dose
Part B: Maximum Observed Plasma Concentration (Cmax) of NGM Metabolites and EE in the Absence and Presence of SUZ
measured Pre-dose up to Day 29 Post-dose
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NGM Metabolites and EE in the Absence and Presence of SUZ
measured Pre-dose up to Day 29 Post-dose
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of NGM Metabolites and EE in the Absence and Presence of SUZ
measured Pre-dose up to Day 29 Post-dose

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