Clinical trial NCT05704556: Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-01-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.).

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
timeFrame: Day 1 to Day 14
measure: Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: Apparent Clearance of VX-548
timeFrame: Day 1 to Day 14
measure: Apparent Renal Clearance of VX-548 and its Metabolite (CLr)
timeFrame: Day 1 to Day 14
measure: Apparent Non-Renal Clearance of VX-548
timeFrame: Day 1 to Day 14
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 to Day 23
measure: Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
timeFrame: Day 1 to Day 2
measure: Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
timeFrame: Day 1 to Day 14
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Infigo Clinical Research
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Tampa
country: United States
facility: Elixia, Phase 1 Clinical Site
state: Florida
city: Houston
country: United States
facility: Southwest Houston Research, Ltd
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
Study officials:
References: