NCT05579431

A Phase 1, First-in-human Study of VX-634

A Phase 1, First-in-human Study of Safety, Tolerability, and Pharmacokinetics of VX-634

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (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, tolerability, and pharmacokinetics (PK) of VX-634 at various doses.

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

• Alpha 1-Antitrypsin Deficiency

Interventions

Type	Name	Description
DRUG	VX-634	Suspension for oral administration.
DRUG	Placebo	Suspension for oral administration.

Timeline

• Start date: 2022-10-13
• Primary completion: 2023-05-24
• Completion: 2023-11-13
• First posted: 2022-10-13
• Last updated: 2024-03-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study