Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment
NCT06529796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-01-20
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.
Conditions
- Focal Segmental Glomerulosclerosis (FSGS)
Interventions
- DRUG
-
IXP
Tablet for oral administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-02
- Primary Completion
- 2024-12-20
- Completion
- 2024-12-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)
NCT03422510 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis
NCT05624723 ·Status: COMPLETED ·Phase: PHASE1
-
Renal Impairment Study of PF-06700841
NCT04260464 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
NCT03703908 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543
NCT05468749 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis
NCT05213624 ·Status: COMPLETED ·Phase: PHASE2
-
A Renal Impairment Study for PF-04965842
NCT03660241 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis
NCT03598036 ·Status: TERMINATED ·Phase: PHASE2
-
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
NCT01740362 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
NCT01367509 ·Status: COMPLETED ·Phase: PHASE1
-
A Renal Impairment Study for PF-06651600
NCT04037865 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants
NCT05363215 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
NCT07268638 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)
NCT02000440 ·Status: COMPLETED ·Phase: PHASE2
-
PK Study of Intranasal RX0041-002 in Subjects With Severe Renal Impairment and Normal Renal Function
NCT02775955 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
NCT03776539 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
NCT00445302 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
NCT07220083 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Pharmacokinetics of HSK21542 in Subjects With Renal Impairment
NCT05947097 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
NCT06586216 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Kidney Function and Healthy Participants
NCT06190678 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
NCT06500702 ·Status: RECRUITING ·Phase: PHASE2
-
Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
NCT02011490 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
NCT02646358 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)
NCT01665391 ·Status: COMPLETED ·Phase: PHASE2