| Trial ID: | L0393 |
| Source ID: | NCT04766476
|
| Associated Drug: |
BMS-963272
|
| Title: |
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver Disease
|
| Interventions: |
Drug: BMS-963272;Other: Placebo matching BMS-963272
|
| Outcome Measures: |
Incidence of adverse events (AEs);Incidence of serious adverse events (SAEs);Incidence of clinically significant changes in vital signs: Blood pressure;Incidence of clinically significant changes in vital signs: Heart rate;Incidence of clinically significant changes in physical examination findings;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval;Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry test;Incidence of clinically significant changes in clinical laboratory results: Hematology tests;Incidence of clinically significant changes in clinical laboratory results: Coagulation tests;Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests;Incidence of clinically significant changes in clinical laboratory results: Liver function tests;Incidence of clinically significant changes in clinical laboratory results: Lipid panel testsPharmacokinetic (PK) sampling: Maximum observed plasma concentration (Cmax);Pharmacokinetic (PK) sampling: Time to maximum observed plasma concentration (Tmax);Pharmacokinetic (PK) sampling: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]);Trough observed plasma concentration (Ctrough)
|
| Sponsor/Collaborators: |
Bristol-Myers Squibb
|
| Gender: |
All
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 1
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
19/02/2021
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 June 2021
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04766476
|
