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

Primary Purpose

Focal Segmental Glomerulosclerosis (FSGS)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VX-147
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Segmental Glomerulosclerosis (FSGS)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • ICON Salt Lake City

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sequence A: VX-147

Sequence B: VX-147

Sequence C: VX-147

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference
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
Cmax of VX-147 Test Compared Under Fed Versus Fasted State
AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2023
Last Updated
September 12, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05955872
Brief Title
A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2023 (Actual)
Primary Completion Date
September 2, 2023 (Actual)
Study Completion Date
September 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Segmental Glomerulosclerosis (FSGS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A: VX-147
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence B: VX-147
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence C: VX-147
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
VX-147
Intervention Description
Tablets for oral administration.
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference
Time Frame
From Day 1 up to Day 16
Title
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
Time Frame
From Day 1 up to Day 16
Title
Cmax of VX-147 Test Compared Under Fed Versus Fasted State
Time Frame
From Day 1 up to Day 16
Title
AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State
Time Frame
From Day 1 up to Day 16
Secondary Outcome Measure Information:
Title
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs
Time Frame
From Day -1 up to Day 27

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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/Exclusion criteria may apply.
Facility Information:
Facility Name
ICON Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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