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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05704556
• Other study ID #: VX22-548-014
• Status: Completed
• Phase: Phase 1
• Start date: February 27, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Renal Insufficiency

Intervention

Drug:
• VX-548
Tablets for oral administration.

Locations

Country	Name	City	State
United States	Infigo Clinical Research	DeLand	Florida
United States	Southwest Houston Research, Ltd	Houston	Texas
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida
United States	GCP Research	Saint Petersburg	Florida
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	Elixia, Phase 1 Clinical Site	Tampa	Florida
United States	Genesis Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

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