A Phase 1 Dose Escalation Study of Intravenous VX-993 in Healthy Adults

Vertex Pharmaceuticals Incorporated88 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenously administered VX-993 at different doses 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-993DRUG

Solution for IV administration.

PlaceboDRUG

Solution for IV 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), inclusive * A total body weight of more than (\>) 50 kg * Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug 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 distribution, metabolism, or excretion Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (1)

ICON Lenexa

Lenexa, Kansas, 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: Day 1 up to Day 16

Part 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 43

Secondary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993

Time frame: Pre-dose up to Day 16

Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993

Time frame: Pre-dose up to Day 43

Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993

Time frame: Pre-dose up to Day 16

Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993

Time frame: Pre-dose up to Day 43

Data from ClinicalTrials.gov

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