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
Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• 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
Locations
United States
Florida
GCP Research
Ocala
Genesis Clinical Research
Tampa
Time Frame
Start Date: 2023-06-12
Completion Date: 2024-06-12
Participants
Target number of participants: 16
Treatments
Experimental: Cohort 1: Severe Renal Impairment
Participants will receive a single dose of IXP on Day 1.
Experimental: Cohort 1: Healthy Participants
Participants will receive a single dose of IXP on Day 1.
Sponsors
Leads: Vertex Pharmaceuticals Incorporated