NCT05518734

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX-708 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of VX-708 in healthy participants

Detailed 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.).

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	VX-708	Solution for intravenous (IV) administration.
DRUG	Itraconazole	Solution for oral administration.
DRUG	Midazolam	Solution for oral administration.
DRUG	Placebo	Placebo matched to VX-708 for IV administration.

Timeline

• Start date: 2022-09-17
• Primary completion: 2023-03-07
• Completion: 2023-03-07
• First posted: 2022-08-29
• Last updated: 2023-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study