A Phase 1 Dose Escalation Study of Intravenous VX-993 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 and Pharmacokinetics of Intravenous VX-993 in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394167
• Other study ID #: VX23-993-002
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: Medical Information
• Phone: 617-341-6777
• Email: medicalinfo[@]vrtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenously administered 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: Recruiting
• Enrollment: 110
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• 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), inclusive

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

• Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug

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 distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• VX-993
Solution for IV administration.
• Placebo
Solution for IV administration.

Locations

Country	Name	City	State
United States	ICON Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

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 16
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 43
Secondary	Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993		Pre-dose up to Day 16
Secondary	Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993		Pre-dose up to Day 43
Secondary	Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993		Pre-dose up to Day 16
Secondary	Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993		Pre-dose up to Day 43