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

NCT05955872 | Completed Phase 1 FDA Drug

• 1 other identifier: VX22-147-010
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Segmental Glomerulosclerosis (FSGS)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs

  From Day -1 up to Day 27

Study Arms (3)

Sequence A: VX-147

EXPERIMENTAL

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.

Drug: VX-147

Sequence B: VX-147

EXPERIMENTAL

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.

Drug: VX-147

Sequence C: VX-147

EXPERIMENTAL

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.

Drug: VX-147

Interventions

VX-147 DRUG

Tablets for oral administration.

Sequence A: VX-147; Sequence B: VX-147; Sequence C: VX-147

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

ICON Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: July 19, 2023
• Primary Completion: September 2, 2023
• Study Completion: September 2, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)