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

April 19, 2024 updated by: Vertex Pharmaceuticals Incorporated

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Edgewater, Florida, United States, 32132
        • Withdrawn
        • Velocity Clinical Research, New Smyrna Beach
      • Ocala, Florida, United States, 34471
        • Recruiting
        • GCP Research
      • Tampa, Florida, United States, 33603
        • Recruiting
        • Genesis Clinical Research
    • Texas
      • Houston, Texas, United States, 77099
        • Withdrawn
        • Southwest Houston Research, Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax) of IXP
Time Frame: Day 1 up to Day 7
Day 1 up to Day 7
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
Day 1 up to Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Day 1 through completion of study participation (up to a maximum of 17 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX19-147-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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