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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: VX-548

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.).

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Medical Information; Phone Number: 617-341-6777; Email: medicalinfo@vrtx.com

Study Locations

• United States
  • Florida
    • DeLand, Florida, United States, 32720
      • Infigo Clinical Research
    • Miami, Florida, United States, 33014-3616
      • Clinical Pharmacology of Miami, LLC
    • Saint Petersburg, Florida, United States, 33705
      • GCP Research
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research
    • Tampa, Florida, United States, 33618
      • Elixia, Phase 1 Clinical Site
  • Texas
    • Houston, Texas, United States, 77099
      • Southwest Houston Research, Ltd
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Severe Renal Impairment; Participants will receive a single dose of VX-548 in a fasted state.	Drug: VX-548; Tablets for oral administration.; Other Names: Suzetrigine
Experimental: Cohort 2: Matched Healthy Participants; Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.	Drug: VX-548; Tablets for oral administration.; Other Names: Suzetrigine
Experimental: Cohort 3: Moderate Renal Impairment; Participants will receive a single dose of VX-548 in a fasted state.	Drug: VX-548; Tablets for oral administration.; Other Names: Suzetrigine
Experimental: Cohort 4: Matched Healthy Participants; Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.	Drug: VX-548; Tablets for oral administration.; Other Names: Suzetrigine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite	Day 1 to Day 14
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite	Day 1 to Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Apparent Clearance of VX-548	Day 1 to Day 14
Apparent Renal Clearance of VX-548 and its Metabolite (CLr)	Day 1 to Day 14
Apparent Non-Renal Clearance of VX-548	Day 1 to Day 14
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Day 1 to Day 23
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma	Day 1 to Day 2
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite	Day 1 to Day 14

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: VX22-548-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No