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

Phase 1

Completed

• Conditions: Acute Pain
• Interventions: Drug: VX-708; Drug: Placebo

• Registration Number: NCT05347394
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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.

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 Timeline

• Study Start: 2022-04-08
• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part B: VX-708	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.
Part A: VX-708	VX-708	Participants will be randomized to receive a single dose of different dose levels of VX-708.
Part A: Placebo	Placebo	Participants will receive placebo matched to VX-708.
Part B: Placebo	Placebo	Participants will receive placebo matched to VX-708.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MAC Clinical Research; 🇬🇧 Manchester, United Kingdom