A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
NCT04634149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2022-06-16
Summary
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.
Conditions
- Moderate Liver Impairment
- Severe Liver Impairment
Interventions
- DRUG
-
BMS-986036
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-11-23
- Primary Completion
- 2022-06-02
- Completion
- 2022-06-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
NCT03515980 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
NCT05981963 ·Status: COMPLETED ·Phase: PHASE1
-
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
NCT00859053 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020
NCT02068053 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants
NCT06088264 ·Status: COMPLETED ·Phase: PHASE1
-
Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032
NCT01019070 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
NCT06433505 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants
NCT05567510 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
NCT06535399 ·Status: COMPLETED ·Phase: PHASE1
-
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
NCT04604496 ·Status: COMPLETED ·Phase: PHASE1
-
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
NCT04831944 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
NCT05847439 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
NCT03289234 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function
NCT04056468 ·Status: COMPLETED ·Phase: PHASE1
-
Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
NCT02982707 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
NCT01708889 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
NCT04249284 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
NCT03210909 ·Status: COMPLETED ·Phase: PHASE1
-
Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
NCT02467335 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
NCT05707390 ·Status: COMPLETED ·Phase: PHASE1
-
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
NCT04193436 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants
NCT04055506 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug
NCT00382668 ·Status: COMPLETED
-
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
-
Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
NCT04887064 ·Status: COMPLETED ·Phase: PHASE1