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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003458-10 | EudraCT Number |
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Business objectives changed.
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This study aims to evaluate the safety, tolerability, of CC-97489
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of CC-97489 | Experimental |
| |
| Administration of Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-97489 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 001 | Leuven | Vlaams Brabant | 3000 | Belgium |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
See Plan Description
See Plan Description
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| Placebo | Other | Specified dose on specified days |
|
| 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 |