Status:
COMPLETED
Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Focal Segmental Glomerulosclerosis (FSGS)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of Inaxaplin (IXP) in participants with mild or moderate hepatic impairment and in matched 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 ...
Eligibility Criteria
Inclusion
- Key
- Cohorts 1 and 3: Participants with Hepatic Impairment
- Cohort 1 (mild impairment): defined as a Child-Pugh total score of 5 to 6 (Child-Pugh Class A)
- Cohort 3 (moderate impairment): defined as a Child-Pugh total score of 7 to 9 (Child-Pugh Class B)
- Cohorts 2 and 4: Healthy Participants
- Participants will be matched during screening to participants with mild (Cohort 1) or moderate (Cohort 3) hepatic impairment according to each of the following parameters: age (± 10 years); sex; and BMI (± 15%)
- Key
Exclusion
- Cohorts 1 and 3: Participants with Hepatic Impairment
- Acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug
- Participants who smoke
- Cohorts 2 and 4: Healthy Participants
- Acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug
- Any condition possibly affecting drug absorption
- Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
August 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06529796
Start Date
August 2 2024
End Date
December 20 2024
Last Update
January 20 2025
Active Locations (3)
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1
Division of Clinical Pharmacology, University of Miami
Miami, Florida, United States, 33136
2
GCP Research
St. Petersburg, Florida, United States, 33705
3
Texas Liver Institute
San Antonio, Texas, United States, 78215