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A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05865171
Collaborator
(none)
16
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: Severe Renal Impairment

Participants will receive a single dose of IXP on Day 1.

Drug: IXP
Tablets for oral administration.
Other Names:
  • VX-147
  • Inaxaplin

    		•
    Experimental: Cohort 1: Healthy Participants

    Participants will receive a single dose of IXP on Day 1.

    Drug: IXP
    Tablets for oral administration.
    Other Names:
  • VX-147
  • Inaxaplin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of IXP [Day 1 up to Day 7]

    2. Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP [Day 1 up to Day 7]

    Secondary Outcome Measures

    1. Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) [Day 1 through completion of study participation (up to a maximum of 17 days)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT05865171
    Other Study ID Numbers:
    • VX19-147-007
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Glomerulosclerosis, Focal Segmental

    Study Results

    No Results Posted as of May 18, 2023