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NCT Number: NCT05955872

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

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.

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Key information

Conditions

Focal Segmental Glomerulosclerosis (FSGS) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulosclerosis, Focal Segmental Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Salt Lake City

Salt Lake City, Utah, 84124, United States

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-147

Drug

Tablets for oral administration.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference

    Time frame: From Day 1 up to Day 16

  2. 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

  3. Cmax of VX-147 Test Compared Under Fed Versus Fasted State

    Time frame: From Day 1 up to Day 16

  4. AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State

    Time frame: 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

    Time frame: From Day -1 up to Day 27

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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