> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-study-to-evaluate-safety-tolerability-and-154db6c4-089a-4297-a3aa-59003d4a5cf2 > Record changed: 2026-10-29 # A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants NCT06345755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) Participants 159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) Lead sponsor Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) Start date 2024-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Title and summary **Summary** The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Short title** A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Official title** A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of VX-407 in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Dates **Completion date** 2025-06-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **First posted** 2024-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Registry last updated** 2025-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Primary completion date** 2025-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Start date** 2024-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Size and sites **Actual participants** 159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Participants** 159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Lead sponsor** Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Identifiers **Registry ID** NCT06345755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **ClinicalTrials.gov ID** NCT06345755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Outcomes ### Primary outcomes 1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: From Enrollment up to Day 10 2. Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: From Enrollment up to Day 23 ### Secondary outcomes 1. Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407 Timeframe: From Day 1 up to Day 6 2. Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407 Timeframe: Days 1, 7, and 14 3. Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407 Timeframe: From Day 1 up to Day 6 4. Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407 Timeframe: Days 1, 7, and 14 5. Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407 Timeframe: On Day 1, and Day 15 6. Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407 Timeframe: On Day 1, and Day 15 7. Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: From Enrollment up to Day 24 8. Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation (test) compared to a Suspension Formulation (reference) Under Fasted Conditions Timeframe: Days 1, 7, and 13 9. Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Under Fasted Conditions Timeframe: Days 1, 7, and 13 10. Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation Under Fed versus Fasted State Timeframe: Days 1, 7, and 13 11. Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Tablet Formulation Under Fed versus Fasted State Timeframe: Days 1, 7, and 13 12. Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: From Enrollment up to Day 22 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes Key Inclusion Criteria: - Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2) - A total body weight of greater than (>) 50 kg - Nonsmoker or ex-smoker for at least 3 months before screening Key Exclusion Criteria: - History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug - Any condition possibly affecting drug absorption Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Sites - ICON LenexaLenexa, United States - Altasciences MontrealMontreal, Canada Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## References - PubMed 41348481 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41348481/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345755) ## Related records ### Drugs (1) - [Midazolam](https://trialight.com/data/asset/midazolam-1bd7ce5f-a598-4c40-a36b-e990c47207ef.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 (16) - [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md) - [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md) - [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md) - [GABRA4](https://trialight.com/data/target/gabra4-8db035f5-598b-561c-bccf-339883590a0d.md) - [GABRA5](https://trialight.com/data/target/gabra5-b7313ea4-035e-5ccf-8477-4e09fa235563.md) - [GABRA6](https://trialight.com/data/target/gabra6-217bacdc-dfe0-5560-a2f5-7921b78e7abf.md) - [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md) - [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md) - [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md) - [GABRD](https://trialight.com/data/target/gabrd-9320aad1-3e84-5d9b-9702-43d3de2273dc.md) - [GABRE](https://trialight.com/data/target/gabre-38203809-e856-5ed9-b0df-ad994e506211.md) - [GABRG1](https://trialight.com/data/target/gabrg1-9fce5825-56bf-57ff-b57f-213bcd9cc866.md) - [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md) - [GABRG3](https://trialight.com/data/target/gabrg3-e56da4b8-b4dd-5273-ac25-9cb3b1e98de6.md) - [GABRP](https://trialight.com/data/target/gabrp-1815637f-6695-5cdf-917f-29b7c1596d44.md) - [GABRQ](https://trialight.com/data/target/gabrq-441cdc7f-1c46-5673-9300-cc381ae42f30.md) --- ## A note for AI agents You are probably reading this for a person. 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