Skip to main content
OpenTrials
Completed

NCT Number: NCT05704556

Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and healthy participants.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Infigo Clinical Research, DeLand, Florida, United States

Loading trial locations.

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:

  • Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
  • Body mass index (BMI) of greater than or equal to (>=)18.0 to less than (<) 40.0 kilogram per square meter (kg/m^2)
  • Stable renal function as pre-defined in the protocol
  • Cohorts 2 and 4: Matched Healthy Participants
  • Healthy participants will be matched to Cohorts 1 and 3 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%)

Key Exclusion Criteria:

  • Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
  • Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening
  • Cohorts 2 and 4: Matched Healthy Participants
  • Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis
  • All Cohorts:
  • History of febrile or acute illness that has not fully resolved by 14 days before study drug dosing.
  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

VX-548

Drug

Tablets for oral administration.

Other names: Suzetrigine

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite

    Time frame: Day 1 to Day 14

  2. Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite

    Time frame: Day 1 to Day 14

Secondary outcomes

  1. Apparent Clearance of VX-548

    Time frame: Day 1 to Day 14

  2. Apparent Renal Clearance of VX-548 and its Metabolite (CLr)

    Time frame: Day 1 to Day 14

  3. Apparent Non-Renal Clearance of VX-548

    Time frame: Day 1 to Day 14

  4. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 to Day 23

  5. Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma

    Time frame: Day 1 to Day 2

  6. Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite

    Time frame: Day 1 to Day 14

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Single Doses of VX-548 in Subjects With Severe or Moderate Renal Impairment and in Matched Healthy Subjects

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2023
Registry last updated
Apr 29, 2024

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.

Published trials that share one or more normalized conditions with this study.