Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02017730 | To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding in Lung Using PET (Positron Emission Tomography) In Healthy Volunteers | PHASE1 | COMPLETED | 20 | — | — | Jan 1, 2014 | Jan 1, 2015 | Jul 7, 2015 | 1 | United States |
The following safety endpoints will be considered, the incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation from the study, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiograms (ECGs), and physical examinations occurring from screening up to study discharge.
Assessed by \[11C\]BMT-136088 tracer lung volume of distribution (VT) before and after single oral dose of BMS-986020.
| Arm | Type | Description |
|---|---|---|
| Part 1: [11C]BMT-136088 (Safety Study) | EXPERIMENTAL | Single PET SCAN with single bolus injection of \[11C\]BMT-136088 |
| Part 2: [11C]BMT-136088 (Test/Retest study) | EXPERIMENTAL | Single PET SCAN with Intravenous (IV) bolus plus infusion of \[11C\]BMT-136088 followed by a re-test PET scan (approximately 6 hours apart) with IV bolus plus infusion of \[11C\]BMT-136088 |
| Part 3: BMS-986020+[11C]BMT-136088 (Receptor Occupancy study) | EXPERIMENTAL | BMS-986020 Tablets or Oral Solution of 4 dose levels from from the 6 dose levels of (50 mg, 150 mg, 300 mg, 600 mg, 1200 mg and 1500 mg) and 3 PET SCANS (Pre-Dose, Post-Dose1, Post-Dose2) with bolus plus infusion of \[11C\]BMT-136088 |
| Part 4: [11C]BMT-136088 (Tissue Distribution study) | EXPERIMENTAL | Single PET SCAN with \[11C\]BMT-136088 to evaluate additional tracer uptake sites in humans other than the lung, such as heart, kidney, liver, gallbladder, etc. |
| Name | Type | Description |
|---|---|---|
| BMS-986020 | DRUG | - |
| [11C]BMT-136088 | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Body weight at least 50kg (110lbs), Body Mass Index (BMI) within 19 to 32 kg/m2, inclusive * Must be in good health as determined by medical history, physical examination, EC...