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The purpose of this study is to assess the safety and tolerability of a novel positron emission tomography (PET) tracer [11C]BMT-136088 in healthy adult subjects for measurement of availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this tracer to assess LPA1 receptor occupancy using [11C]BMT-136088 in the human lung following oral administration of Bristol Myers Squibb (BMS)-986020.
End point Classification: Pharmacokinetics/Pharmacodynamics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: [11C]BMT-136088 (Safety Study) | Experimental | Single PET SCAN with single bolus injection of [11C]BMT-136088 |
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| 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 |
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| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986020 | Drug |
| ||
| [11C]BMT-136088 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall safety and tolerability of novel tracer [11C]BMT-136088 | 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. | Approximately up to 90 days |
| Lung LPA1 percentage receptor occupancy of BMS-986020 | Assessed by [11C]BMT-136088 tracer lung volume of distribution (VT) before and after single oral dose of BMS-986020. | Up to 2 days post BMS-986020 administration |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure-response relationship between lung LPA1 percentage receptor occupancy and BMS-986020 plasma concentration. | Up to 48 hr postdose (Approximately up to Day 3) | |
| Maximum observed concentration (Cmax) of BMS-986020 | 13 timepoints up to Day 3 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Pet Center | New Haven | Connecticut | 06520 | United States |
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| Drug |
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| Time of maximum observed concentration (Tmax) of BMS-986020 | 13 timepoints up to Day 3 |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986020 | 13 timepoints up to Day 3 |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986020 | 13 timepoints up to Day 3 |
| Half life (T-HALF) of BMS-986020 | 13 timepoints up to Day 3 |
| Safety of single oral dose of BMS-986020 where [11C]BMT-136088 is administered to healthy subjects | Safety based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations | Approximately up to 90 days |