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

NCT05704556 | Completed Phase 1 FDA Drug

• 1 other identifier: VX22-548-014
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (4)

Cohort 1: Severe Renal Impairment

EXPERIMENTAL

Participants will receive a single dose of VX-548 in a fasted state.

Drug: VX-548

Cohort 2: Matched Healthy Participants

EXPERIMENTAL

Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.

Drug: VX-548

Cohort 3: Moderate Renal Impairment

EXPERIMENTAL

Participants will receive a single dose of VX-548 in a fasted state.

Drug: VX-548

Cohort 4: Matched Healthy Participants

EXPERIMENTAL

Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.

Drug: VX-548

Interventions

VX-548 DRUG

Tablets for oral administration.

Also known as: Suzetrigine

Cohort 1: Severe Renal Impairment; Cohort 2: Matched Healthy Participants; Cohort 3: Moderate Renal Impairment; Cohort 4: Matched Healthy Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (7)

Infigo Clinical Research

DeLand, Florida, 32720, United States

Location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014-3616, United States

Location

GCP Research

St. Petersburg, Florida, 33705, United States

Location

Genesis Clinical Research

Tampa, Florida, 33603, United States

Location

Elixia, Phase 1 Clinical Site

Tampa, Florida, 33618, United States

Location

Southwest Houston Research, Ltd

Houston, Texas, 77099, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: February 27, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)