A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-993

A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-993 in Healthy Adult Subjects

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-993 in healthy adult participants.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: VX-993

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.).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON Salt Lake City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 absorption, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VX-993; Participants will be randomized to receive VX-993 in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two VX-993 formulations and the effect of food on the pharmacokinetics of VX-993.	Drug: VX-993; Tablet and Suspension for Oral Administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of VX-993	From Day 1 up to Day 28
Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993	From Day 1 up to Day 28
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993	From Day 1 up to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of VX-993 Metabolite	From Day 1 up to Day 28
Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993 Metabolite	From Day 1 up to Day 28
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 Metabolite	From Day 1 up to Day 28
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Day 28

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VX24-993-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No