| Trial ID: | L0809 |
| Source ID: | NCT03329885
|
| Associated Drug: |
BMS-986251
|
| Title: |
A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Health
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT03329885
|
| Conditions: |
Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: BMS-986251;Other: Placebo
|
| Outcome Measures: |
Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation;Number of Participants With Potentially Clinically Significant Changes in Vital Signs;Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters;Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Parameters;Maximum Observed Plasma Concentration (Cmax);Time of Maximum Observed Plasma Concentration (Tmax);Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-t)];Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] (Part A);Terminal Elimination Half-life, Calculated as 0.693/Kel [t(1/2)];Apparent (Oral) Clearance (CL/F) Calculated as Dose/[AUC(0-inf)] for Single Dose;Apparent Volume of Distribution at Terminal Phase [V(z)/F];Cumulative Urinary Excretion (of the Unchanged Drug) [Ae(t)];Amount Excreted Unchanged in Urine (% of Dose) [Fe(Urine)%];Renal Clearance [CL(R)];Area Under the Concentration-time Curve Over 24 Hours (One Dosing Interval) [AUC(0-24)] (Part B);Ratio of AUC(0-24) Following Last Dose to AUC(0-24) Following First Dose [AR[AUC(0-24)]] (Part B);Ratio of Cmax Following Last Dose to Cmax Following First Dose [AR(Cmax)] (Part B);Pre-dose Plasma Concentration (Cpre) (Part B);Inhibition at Time t [I(t)] (Part B)Maximum Observed Inhibition [I(Max)];Time of Maximum Observed Inhibition [t(Imax)];Time of Inhibition Above 50% [t(I>50%)];Time of Inhibition Above 90% [t(I>90%)];Pre-dose Inhibition [I(Pre)] (Part B)
|
| Sponsor/Collaborators: |
Bristol-Myers Squibb
|
| Gender: |
All
|
| Age: |
18 Years70 Years
|
| Phases: |
Phase 1/Phase 2
|
| Enrollment: |
38
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
31/10/2017
|
| Completion Date: |
--
|
| Results First Posted: |
21/10/2019
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT03329885
|
