A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics, of VX-993

Last updated: July 11, 2024
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

1

Condition

Pain

Treatment

Placebo

VX-993

Clinical Study ID

NCT06226454
VX23-993-003
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-993 at different doses in healthy participants.

Eligibility Criteria

Inclusion

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

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

Exclusion

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, distribution, metabolism, orexcretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 39
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
January 04, 2024
Estimated Completion Date:
June 12, 2024

Study 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.).

Connect with a study center

  • ICON Salt Lake City

    Salt Lake City, Utah 84124
    United States

    Site Not Available

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