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

NCT05347394 | Completed Phase 1 FDA Drug

• 2 other identifiers: VX21-708-0022021-005559-35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (4)

Part A: VX-708

EXPERIMENTAL

Participants will be randomized to receive a single dose of different dose levels of VX-708.

Drug: VX-708

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to VX-708.

Drug: Placebo

Part B: VX-708

EXPERIMENTAL

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

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to VX-708.

Drug: Placebo

Interventions

VX-708 DRUG

Solution or suspension for oral administration.

Part A: VX-708; Part B: VX-708

Placebo DRUG

Placebo matched to VX-708 for oral administration.

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: April 8, 2022
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)