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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


Description

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants.This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Trial Eligibility

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.

Study Info

Organization

Vertex Pharmaceuticals Incorporated


Primary Outcome

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


Outcome Timeframe From Enrollment up to Day 10

NCTID NCT06345755

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-04-17

Completion Date 2025-04

Enrollment Target 95

Interventions

DRUG VX-407

DRUG Placebo

DRUG Midazolam

Locations Recruiting

ICON Lenexa

United States, Kansas, Lenexa


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