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

A Phase 1, Open Label, Randomized, Crossover Study Evaluating the Relative Bioavailability and Food Effect of a VX-147 Test Tablet Formulation Compared to a Reference Tablet Formulation in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05955872

Enrollment

Registered

2023-07-21

Start date

2023-07-19

Completion date

2023-09-02

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Segmental Glomerulosclerosis (FSGS)

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.).

Interventions

DRUGVX-147

Tablets for oral administration.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key 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/

Design outcomes

Primary

Measure	Time frame
Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference	From Day 1 up to Day 16
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
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026