> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/effects-of-vx-407-on-the-pharmacokinetics-of-combined-oral-6d18cbb8-4df4-4252-bd84-3f7fb18d00b2 > Record changed: 2026-10-13 # Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives NCT07792408 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) Participants 148 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) Lead sponsor Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) Start date 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Title and summary **Summary** The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Short title** Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Official title** A Phase 1, Open-label Drug Interaction Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Dates **Completion date** 2027-03-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **First posted** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Primary completion date** 2027-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Start date** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Size and sites **Participants** 148 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Planned participants** 148 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Lead sponsor** Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Identifiers **Registry ID** NCT07792408 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **ClinicalTrials.gov ID** NCT07792408 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07792408) ## Related records ### Drugs (3) - [Drospirenone](https://trialight.com/data/asset/drospirenone-9b602c10-48da-4ba8-ace9-5b9f942ad491.md) - [Ethinyl estradiol](https://trialight.com/data/asset/ethinyl-estradiol-db91b58c-a527-4ab2-bf5b-c81e3958d171.md) - [Levonorgestrel](https://trialight.com/data/asset/levonorgestrel-39655add-4fa8-46e3-b2a3-c0338caf8c0b.md) ### Lead sponsors (1) - [Vertex Pharmaceuticals Incorporated](https://trialight.com/data/company/vertex-pharmaceuticals-incorporated-871a0178-8d63-4b70-a78f-fbfa131729c0.md) ### Conditions (2) - [Autosomal dominant polycystic kidney disease](https://trialight.com/data/condition/autosomal-dominant-polycystic-kidney-disease-4beb5bfd-d32f-5dcd-bf5a-99032974b831.md) Primary condition - [Isolated familial wooly hair disorder](https://trialight.com/data/condition/isolated-familial-wooly-hair-disorder-835db8a4-7f99-5327-808d-cb8d49cb3e85.md) ### Targets (3) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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