NOT YET RECRUITINGPhase 1

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

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

148 participants

Sites

0 locations

Start Date

August 2026

Completion

March 2027

Autosomal Dominant Polycystic Kidney Disease (ADPKD)VX-407LNG/EENGM/EE

Enrollment & Timeline

Not Yet Recruiting

Target enrollment (estimated)

Target N

148

participants

Sites

locations

Duration

7 months

total trial span

Rate

pts/month needed

Aug 2026Month 1 of 7Mar 2027

14% of trial timeline elapsed6 months to primary endpoint

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

NOT YET RECRUITINGPhase 1

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

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

148 participants

Sites

0 locations

Start Date

August 2026

Completion

March 2027

Autosomal Dominant Polycystic Kidney Disease (ADPKD)VX-407LNG/EENGM/EE

Enrollment & Timeline

Not Yet Recruiting

Target enrollment (estimated)

Target N

148

participants

Sites

locations

Duration

7 months

total trial span

Rate

pts/month needed

Aug 2026Month 1 of 7Mar 2027

14% of trial timeline elapsed6 months to primary endpoint

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Primary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/EE in the Absence and Presence of VX-407

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

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

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

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

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

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

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

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

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

female

Healthy Volunteers

Yes

View full criteria

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.

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