Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment
NCT05560464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2024-03-20
Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.
Conditions
Interventions
- DRUG
-
VX-548
Tablets 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
- 2022-10-14
- Primary Completion
- 2023-07-24
- Completion
- 2023-07-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males
NCT04183517 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
NCT02170220 ·Status: COMPLETED ·Phase: PHASE1
-
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
NCT04604496 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
NCT05624710 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects
NCT05391724 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment
NCT07248839 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Evaluate Severe Hepatic Impairment on Dacomitinib PK
NCT03865446 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function
NCT02436447 ·Status: COMPLETED ·Phase: PHASE1
-
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
NCT06952634 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Pharmacokinetics (PK) and Safety of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function
NCT06858696 ·Status: RECRUITING ·Phase: PHASE1
-
Study of Telaprevir in Subjects With Hepatic Impairment
NCT00509210 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001
NCT06619054 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
NCT01433458 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
NCT02210247 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects
NCT02663687 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment
NCT04305392 ·Status: UNKNOWN ·Phase: PHASE1
-
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
NCT02857868 ·Status: COMPLETED ·Phase: PHASE1
-
Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)
NCT02061826 ·Status: UNKNOWN
-
A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment
NCT00373243 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
NCT00099450 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
NCT04887064 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects
NCT03824678 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
NCT06425198 ·Status: COMPLETED ·Phase: PHASE1
-
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
NCT03515980 ·Status: COMPLETED ·Phase: PHASE1
-
An Investigational Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
NCT04631549 ·Status: UNKNOWN ·Phase: PHASE1