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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: VX-708; Drug: Placebo

Detailed Description

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
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • MAC Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: VX-708; Participants will be randomized to receive a single dose of different dose levels of VX-708.	Drug: VX-708; Solution or suspension for oral administration.
Placebo Comparator: Part A: Placebo; Participants will receive placebo matched to VX-708.	Drug: Placebo; Placebo matched to VX-708 for oral administration.
Experimental: Part B: VX-708; Participants will be randomized to receive multiple doses of different dose levels of VX-708. The dose levels will be determined based on the data from Part A.	Drug: VX-708; Solution or suspension for oral administration.
Placebo Comparator: Part B: Placebo; Participants will receive placebo matched to VX-708.	Drug: Placebo; Placebo matched to VX-708 for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Day 25
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses	From Day 1 up to Day 25

Secondary Outcome Measures

Outcome Measure	Time Frame
Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708	From Day 1 up to Day 25
Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test	From Day 1 up to Day 11

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: VX21-708-002; 2021-005559-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No