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

Acute Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347394
• Other study ID #: VX21-708-002
• Secondary ID: 2021-005559-35
• Status: Completed
• Phase: Phase 1
• Start date: April 8, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: May 2023
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• VX-708
Solution or suspension for oral administration.
• Placebo
Placebo matched to VX-708 for oral administration.

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test		From Day 1 up to Day 11