Back to resultsA Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment
Primary Purpose
Renal Impairment
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IXP
Sponsored by
About this trial
This is an interventional basic science trial for Renal Impairment
Eligibility Criteria
Key Inclusion Criteria: Body mass index (BMI) of 18.5 to 40.0 kilogram per meter square (kg/m^2) Stable renal function for at least 1 month prior to enrollment Key Exclusion Criteria: Uncontrolled hypertension Any condition possibly affecting drug absorption Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Velocity Clinical Research, New Smyrna BeachRecruiting
- GCP ResearchRecruiting
- Southwest Houston Research, LtdRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1: Severe Renal Impairment
Cohort 1: Healthy Participants
Arm Description
Participants will receive a single dose of IXP on Day 1.
Participants will receive a single dose of IXP on Day 1.
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of IXP
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
Secondary Outcome Measures
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Full Information
NCT ID
NCT05865171
First Posted
May 9, 2023
Last Updated
August 18, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT05865171
Brief Title
A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment
Official Title
A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Safety of a Single Dose of Inaxaplin in Subjects With Severe Renal Impairment and Healthy Subjects With Normal Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of Inaxaplin (IXP) in participants with severe renal impairment and healthy participants with normal renal function.
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
Renal Impairment
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (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 IXP on Day 1.
Arm Title
Cohort 1: Healthy Participants
Arm Type
Experimental
Arm Description
Participants will receive a single dose of IXP on Day 1.
Intervention Type
Drug
Intervention Name(s)
IXP
Other Intervention Name(s)
VX-147, Inaxaplin
Intervention Description
Tablets for oral administration.
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of IXP
Time Frame
Day 1 up to Day 7
Title
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
Time Frame
Day 1 up to Day 7
Secondary Outcome Measure Information:
Title
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Day 1 through completion of study participation (up to a maximum of 17 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Body mass index (BMI) of 18.5 to 40.0 kilogram per meter square (kg/m^2)
Stable renal function for at least 1 month prior to enrollment
Key Exclusion Criteria:
Uncontrolled hypertension
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
Velocity Clinical Research, New Smyrna Beach
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Name
GCP Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
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
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
A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment
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