A Phase 1 Dose Escalation Study of VX-973 in Healthy Participants

Vertex Pharmaceuticals Incorporated30 enrolled

Overview

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 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.).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

VX-973DRUG

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: * 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 * 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, distribution, metabolism, or excretion Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (1)

ICON Salt Lake City

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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

Time frame: From Day -1 up to Day 30

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

Time frame: From Day -1 up to Day 85

Secondary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973

Time frame: From Day 1 up to Day 30

Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973

Time frame: From Day 1 up to Day 85

Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973

Time frame: From Day 1 up to Day 30

Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973

Time frame: From Day 1 up to Day 85

Part A: Time Taken for VX-973 to Reach Maximum Concentration (tmax)

Time frame: From Day 1 up to Day 30

Part B: Time Taken for VX-973 to Reach Maximum Concentration (tmax)

Time frame: From Day 1 up to Day 85

Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test

Time frame: From Day 1 up to Day 53

Data from ClinicalTrials.gov

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