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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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