A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment
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
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2024
CompletedJuly 12, 2024
July 1, 2024
1 year
May 9, 2023
July 11, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Observed Plasma Concentration (Cmax) of IXP
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
Day 1 up to Day 7
Secondary Outcomes (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)
Study Arms (2)
Cohort 1: Severe Renal Impairment
EXPERIMENTALParticipants will receive a single dose of IXP on Day 1.
Cohort 1: Healthy Participants
EXPERIMENTALParticipants will receive a single dose of IXP on Day 1.
Interventions
Tablets for oral administration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Uncontrolled hypertension
- Any condition possibly affecting drug absorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
GCP Research
Ocala, Florida, 34471, United States
Genesis Clinical Research
Tampa, Florida, 33603, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2023
First Posted
May 18, 2023
Study Start
June 12, 2023
Primary Completion
June 12, 2024
Study Completion
June 12, 2024
Last Updated
July 12, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
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