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

NCT07792408
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Phase
Phase 1
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Recruitment status
Not yet recruiting
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Participants
148
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Start date
2026-08-28
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Summary
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
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Short title
Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives
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Official title
A Phase 1, Open-label Drug Interaction Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-03-20
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First posted
2026-08-28
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Registry last updated
2026-08-28
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Primary completion date
2027-03-11
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Start date
2026-08-28
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Participants
148
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Participant count basis
Estimated
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Planned participants
148
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Protocol amendments
0
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Registry sponsor category
Industry
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07792408
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ClinicalTrials.gov ID
NCT07792408
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/EE in the Absence and Presence of VX-407

    Timeframe: From Day 1 up to Day 7 and Day 21 up to Day 27

  2. 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

    Timeframe: From Day 1 up to Day 9 and Day 23 up to Day 31

  3. Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of NET and EE in the Absence and Presence of VX-407

    Timeframe: From Day 1 up to Day 5 and Day 19 up to Day 23

  4. Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of VX-407

    Timeframe: From Day 1 up to Day 7 and Day 21 up to Day 27

  5. 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

    Timeframe: From Day 1 up to Day 7 and Day 21 up to Day 27

  6. 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

    Timeframe: From Day 1 up to Day 9 and Day 23 up to Day 31

  7. 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

    Timeframe: From Day 1 up to Day 5 and Day 19 up to Day 23

  8. 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

    Timeframe: From Day 1 up to Day 7 and Day 21 up to Day 27

  1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Day 1 up to Day 36

  2. Part B (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Day 1 Up to Day 39

  3. Part C (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Day 1 up to Day 32

  4. Part D (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Day 1 up to Day 36

  5. Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407

    Timeframe: Days 9, 15 and 21 up to Day 27

  6. Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

    Timeframe: Days 11, 17 and 23 up to Day 31

  7. Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

    Timeframe: Days 7, 13 and 19 up to Day 23

  8. Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

    Timeframe: Days 9, 15 and 21 up to Day 27

  9. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

    Timeframe: Days 9, 15 and 21 up to Day 27

  10. Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

    Timeframe: Days 11, 17 and 23 up to Day 31

  11. Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

    Timeframe: Days 7, 13 and 19 up to Day 23

  12. Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

    Timeframe: Days 9, 15 and 21 up to Day 27

Sources for outcomes
clinicaltrials.gov

Sex
Female
Age groups
Adults
Minimum age
18 Years
Maximum age
50 Years
Healthy volunteers
Yes

Key Inclusion Criteria:

  • Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2), inclusive
  • A total body weight of greater than (>) 50 kg

Key Exclusion Criteria:

  • History of febrile illness within 5 days before the first dose of study drug
  • Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug

Other protocol defined Inclusion/Exclusion criteria will apply.

Sources for eligibility
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Related records

Drugs (3)

Lead sponsors (1)

Conditions (2)

Targets (3)