A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147

Phase 1

Completed

• Conditions: Focal Segmental Glomerulosclerosis (FSGS)
• Interventions: Drug: VX-147

• Registration Number: NCT05955872
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

The purpose of the study is to evaluate the relative bioavailability (BA) and the effect of food on the pharmacokinetics (PK), and the safety and tolerability of VX-147 test tablet formulation.

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 Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study Start: 2023-07-19
• Study First Posted: 2023-07-21
• Status Verified: 2023-09
• Primary Completion: 2023-09-02
• Study Completion: 2023-09-02
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2), inclusive
• A total body weight greater than 50 kg

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

Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A: VX-147	VX-147	Participants will receive VX-147 reference tablet under fasted condition in Treatment Period 1, then VX-147 test tablet under fed condition in Treatment Period 2, and VX-147 test tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.
Sequence B: VX-147	VX-147	Participants will receive VX-147 test tablet under fed condition in Treatment Period 1, then VX-147 test tablet under fasted condition in Treatment Period 2, and VX-147 reference tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.
Sequence C: VX-147	VX-147	Participants will receive VX-147 test tablet under fasted condition in Treatment Period 1, then VX-147 reference tablet under fasted condition in Treatment Period 2, and VX-147 test tablet under fed condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-147 Test Compared to VX-147 Reference	From Day 1 up to Day 16
Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference	From Day 1 up to Day 16
Cmax of VX-147 Test Compared Under Fed Versus Fasted State	From Day 1 up to Day 16
AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State	From Day 1 up to Day 16

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs	From Day -1 up to Day 27

Trial Locations

Locations (1)

ICON Salt Lake City; 🇺🇸 Salt Lake City, Utah, United States