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

Focal Segmental Glomerulosclerosis (FSGS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05955872
• Other study ID #: VX22-147-010
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2023
• Est. completion date: September 2, 2023

Study information

• Verified date: September 2023
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2, 2023
• Est. primary completion date: September 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis (FSGS)
• Glomerulosclerosis, Focal Segmental

Intervention

Drug:
• VX-147
Tablets for oral administration.

Locations

Country	Name	City	State
United States	ICON Salt Lake City	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference		From Day 1 up to Day 16
Primary	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
Primary	Cmax of VX-147 Test Compared Under Fed Versus Fasted State		From Day 1 up to Day 16
Primary	AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State		From Day 1 up to Day 16
Secondary	Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs		From Day -1 up to Day 27