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| Name | Class |
|---|---|
| Yale University | OTHER |
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The purpose of this study is to evaluate the binding of a novel tracer, [11C]TASP0410699, using Positron Emission Tomography (PET) scans with or without dosing of TS-121
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PART 1 (Test/Retest) | Experimental | Dosing with [11C]TASP0410699 for PET imaging without dosing of TS-121 |
|
| PART 2 (PET Receptor Occupancy Study) | Experimental | Dosing with [11C]TASP0410699 for PET imaging with dosing of TS-121 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-121 | Drug | Oral |
| |
| [11C]TASP0410699 |
| Measure | Description | Time Frame |
|---|---|---|
| Positron emission tomography measure (receptor occupancy) | Day 1 through Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of TS-121 | Area under the plasma concentration (AUC) from time zero to time of last measurable concentration | Day 1 through Day 3 |
| Pharmacokinetic parameters of TS-121 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard E. Carson, Ph.D. | Yale University | Principal Investigator |
| Shoji Yasuda | Taisho Pharmaceutical R&D Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University PET Center | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| C000623389 | TASP0410699 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Drug |
Intravenous radiotracer |
|
| Positron Emission Tomography (PET) | Radiation | Imaging scanning procedure |
|
Maximum concentration (Cmax)
| Day 1 through Day 3 |
| Pharmacokinetic parameters of TS-121 | Time to attain cmax (Tmax) | Day 1 through Day 3 |
| Composite safety as assessed by clinical laboratory tests, 12-lead ECG, vital signs, adverse events and physical examinations | up to Day 11 |