A Phase 1 Dose Escalation Study of VX-993 in Healthy Participants

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 VX-993 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05653323
• Other study ID #: VX22-993-001
• Secondary ID: 2022-002413-42
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2022
• Est. completion date: September 12, 2023

Study information

• Verified date: October 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 (PK), and pharmacodynamics (PD) of VX-993 at different doses 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: 70
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)

• A total body weight of more than (>) 50 kg

• Participants of non-childbearing potential

• Nonsmoker or ex-smoker for at least 3 months before screening

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

Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• VX-993
Suspension for oral administration.
• Placebo
Suspension 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	Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 up to Day 25
Primary	Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		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		Pre-dose up to Day 25
Secondary	Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993		Pre-dose up to Day 25
Secondary	Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993		Pre-dose up to Day 25
Secondary	Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993		Pre-dose up to Day 25
Secondary	Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993		Pre-dose up to Day 25
Secondary	Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test		Day 1, Day 10, and Day 11