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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose regimen 1 | Experimental | Varied doses |
|
| Dose regimen 2 | Experimental | Varied doses |
|
| Placebo | Experimental | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velusetrag | Drug | Capsules |
| |
| Velusetrag |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of repeat dosing of velusetrag | Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite | Cmax (maximum observed concentration), Tmax (time of maximum observed concentration), AUC (area under the concentration-time curve) | Days 1, 7, 8, 14, 15, 21 at predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose and 24 hours postdose (and 48 and 72 h post Day 21 dose) |
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Inclusion Criteria:
• Is in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (PE), vital signs (VS) (including blood pressure and pulse rate measurement), 12-lead ECG, and clinical laboratory tests.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Development | Miramar | Florida | 33025 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C533727 | TD-5108 |
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| Drug |
Capsules |
|
| Placebo | Drug | Capsules |
|
| Profile of urine PK of velusetrag and metabolite |
Ae (amount excreted in urine), fe (fraction excreted in urine), CLr (renal clearance) |
| Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose |
| Pharmacodynamic effects of velusetrag | weekly bowel movement frequency | 3 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |