NCT06392659

A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

A Phase 1, Open-label Study Evaluating the Effect of VX-993 on the Pharmacokinetics of Midazolam, and the Effect of Itraconazole and Gemfibrozil on the Pharmacokinetics of VX-993, in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (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 pharmacokinetics (PK), drug-drug interaction, and safety and tolerability of VX-993 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-993	Suspension for Oral Administration.
DRUG	Gemfibrozil	Tablets for Oral Administration.
DRUG	Itraconazole	Capsules for Oral Administration.
DRUG	Midazolam	Solution for Oral Administration.

Timeline

• Start date: 2024-05-02
• Primary completion: 2024-07-02
• Completion: 2024-07-02
• First posted: 2024-04-30
• Last updated: 2024-08-01

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study