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Completed

NCT Number: NCT05347394

A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of VX-708 in healthy participants.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MAC Clinical Research

Manchester, United Kingdom

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male and female of non-childbearing potential are eligible
  • Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m^2)
  • A total body weight greater than (>) 50 kg

Key Exclusion Criteria:

  • History of febrile illness or other acute illness within 14 days before the first dose of study drug
  • Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
  • History of cardiac dysrhythmias

Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

VX-708

Drug

Solution or suspension for oral administration.

Placebo

Drug

Placebo matched to VX-708 for oral administration.

Primary outcomes

  1. Parts A and 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 25

  2. Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses

    Time frame: From Day 1 up to Day 25

Secondary outcomes

  1. Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708

    Time frame: From Day 1 up to Day 25

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

    Time frame: From Day 1 up to Day 11

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral VX-708 in Healthy Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2022
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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