A Phase 1, First-in-human Study of VX-634

Vertex Pharmaceuticals Incorporated127 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-634 at various doses.

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.).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

127

Conditions

Alpha 1-Antitrypsin Deficiency

Interventions

VX-634DRUG

Suspension for oral administration.

PlaceboDRUG

Suspension for oral administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Participants of age between 18 to 55 years (inclusive) * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>)50 kg * Participants of non childbearing potential * Non smoker or ex-smoker for at least 3 months before screening Key Exclusion Criteria: * Any condition possibly affecting drug absorption Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (5)

Celerion - Tempe

Tempe, Arizona, United States

University of Florida

Gainesville, Florida, United States

Central Florida Pulmonary Group, P.A.

Orlando, Florida, United States

ICON Lenexa

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

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

Time frame: Day 1 up to Day 20

Secondary Outcomes

Part A and B: Maximum Observed Plasma Concentration (Cmax) of VX-634

Time frame: Day 1 up to Day 20

Part A and B: Area Under the Concentration Versus Time Curve (AUC) of VX-634

Time frame: Day 1 up to Day 20

Part A and B: Urine Concentration of VX-634

Time frame: Part A Cohort A3: Days 1 and 5; Part B Cohort B3: Days 1, 10 and 11

Data from ClinicalTrials.gov

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