Back to resultsEvaluation of the Pharmacokinetics and Safety of VX 548 in Participants With Renal Impairment
Primary Purpose
Pain
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VX-548
Sponsored by
About this trial
This is an interventional treatment trial for Pain
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.
Sites / Locations
- Clinical Pharmacology of Miami, LLCRecruiting
- GCP ResearchRecruiting
- Genesis Clinical ResearchRecruiting
- Southwest Houston Research, LtdRecruiting
- Clinical Trials of Texas, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1: Severe Renal Impairment
Cohort 2: Matched Healthy Participants
Cohort 3: Moderate Renal Impairment
Cohort 4: Matched Healthy Participants
Arm Description
Participants will receive a single dose of VX-548 in a fasted state.
Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.
Participants will receive a single dose of VX-548 in a fasted state.
Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Secondary Outcome Measures
Apparent Clearance of VX-548
Apparent Renal Clearance of VX-548 and its Metabolite (CLr)
Apparent Non-Renal Clearance of VX-548
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
Full Information
NCT ID
NCT05704556
First Posted
January 19, 2023
Last Updated
September 1, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT05704556
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Severe Renal Impairment
Arm Type
Experimental
Arm Description
Participants will receive a single dose of VX-548 in a fasted state.
Arm Title
Cohort 2: Matched Healthy Participants
Arm Type
Experimental
Arm Description
Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.
Arm Title
Cohort 3: Moderate Renal Impairment
Arm Type
Experimental
Arm Description
Participants will receive a single dose of VX-548 in a fasted state.
Arm Title
Cohort 4: Matched Healthy Participants
Arm Type
Experimental
Arm Description
Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.
Intervention Type
Drug
Intervention Name(s)
VX-548
Intervention Description
Tablets for oral administration.
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Time Frame
Day 1 to Day 14
Title
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 Outcome Measure Information:
Title
Apparent Clearance of VX-548
Time Frame
Day 1 to Day 14
Title
Apparent Renal Clearance of VX-548 and its Metabolite (CLr)
Time Frame
Day 1 to Day 14
Title
Apparent Non-Renal Clearance of VX-548
Time Frame
Day 1 to Day 14
Title
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
Title
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
Time Frame
Day 1 to Day 2
Title
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
Time Frame
Day 1 to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Information
Phone
617-341-6777
Email
medicalinfo@vrtx.com
Facility Information:
Facility Name
Clinical Pharmacology of Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33014-3616
Country
United States
Individual Site Status
Recruiting
Facility Name
GCP Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Houston Research, Ltd
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Learn more about this trial
Evaluation of the Pharmacokinetics and Safety of VX 548 in Participants With Renal Impairment
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