A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults

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-973 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05866055
• Other study ID #: VX22-973-001
• Secondary ID: 2022-003301-30
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2023
• Est. completion date: April 4, 2024

Study information

• Verified date: May 2024
• 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 doses of VX-973 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: 30
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• 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 that has not fully resolved 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-973
Suspension for oral administration.
• Placebo
Suspension for oral administration.
• Midazolam
Syrup for oral administration.

Locations

Country	Name	City	State
United Kingdom	PAREXEL International	Harrow

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)		From Day 1 up to Day 31
Primary	Part 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 43
Secondary	Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973		From Day 1 up to Day 30
Secondary	Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973		From Day 1 up to Day 43
Secondary	Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973		From Day 1 up to Day 30
Secondary	Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973		From Day 1 up to Day 43
Secondary	Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-973		Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose
Secondary	Part B: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-973		Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose