Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants
Study Details
Study Description
Brief Summary
This study aims to evaluate the safety, tolerability, of CC-97489
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Administration of CC-97489
|
Drug: CC-97489
Specified dose on specified days
|
| Experimental: Administration of Placebo
|
Other: Placebo
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events (AEs) [28 days after the last dose]
- Incidence of Serious Adverse Events (SAEs) [28 days after the last dose]
- Number of participants with clinically significant changes in electrocardiogram parameters [Day 21]
- Incidence of clinically significant changes in vital signs: Body temperature [Day 21]
- Incidence of clinically significant changes in vital signs: Respiratory rate [Day 21]
- Incidence of clinically significant changes in vital signs: Blood pressure [Day 21]
- Incidence of clinically significant changes in vital signs: Heart rate [Day 21]
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Day 18]
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Day 18]
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Day 18]
Secondary Outcome Measures
- Pharmacokinetics - Maximum observed plasma concentration (Cmax) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Minimum plasma drug concentration (Cmin) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Time to maximum observed plasma concentration (Tmax) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Area under the plasma concentration (AUC)-time curve from time zero extrapolated to infinity (AUC0-∞) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Area under the plasma concentration-time curve from time zero to time t, where t is the time point of the last measurable concentration (AUC0-t) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau (τ) where τ is the dosing interval (AUC0- 0-τ) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Terminal elimination half-life in plasma (t½,z) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Apparent total plasma clearance when dosed orally (CL/F) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Apparent total volume of distribution when dosed orally (Vz/F) [Up to 96 hours after the last dose of study drug]
- Pharmacokinetics - Ratio of accumulation based on Day 1 and Day 14 AUC0- 0-τ and Cmax, as appropriate (Rac) [Up to 96 hours after the last dose of study drug]
- Pharmacodynamics - Evaluation of monoacylglycerol lipase (MGLL) enzymatic inhibition by CC-97489 in peripheral blood mononuclear cells (PBMCs) [Up to 168 hours after the last dose of study drug]
- Pharmacodynamics: Peripheral blood mononuclear cell (PBMC) fatty acid amide hydrolase (FAAH) inhibition [Up to 168 hours after the last dose of study drug]
- Pharmacodynamics - Measurement of : plasma and whole-blood anandamide (AEA) levels [Up to 168 hours after the last dose of study drug]
- Pharmacodynamics - Measurement of plasma and whole-blood 2-arachidonoylglycerol (2-AG) levels [Up to 168 hours after the last dose of study drug]
Eligibility Criteria
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
-
In good health, as determined by the investigator based on past medical history, physical examination, vital signs and clinical laboratory safety tests at screening.
-
Body mass index (BMI) ≥ 18 and ≤ 33 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
Exclusion Criteria:
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
Other protocol-defined inclusion/exclusion criteria apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven campus Gasthuisberg | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CC-97489-CP-001
- 2019-003458-10