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This is a Phase 1, single center, single-ascending dose, randomized study
Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTP-730, 5 mg | Experimental | oral suspension, once daily. |
|
| CTP-730, 10 mg | Experimental | Oral Suspension, once daily. |
|
| CTP-730, 20 mg | Experimental | Oral Suspension, once daily. |
|
| CTP-730, 30 mg | Experimental | Oral Suspension, once daily. |
|
| CTP-730, 40 mg | Experimental | Oral Suspension, once daily. |
|
| CTP-730, 50 mg | Experimental | Oral Suspension, once daily. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-730 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse events | 3 days | |
| Pharmacokinetics parameters | Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose | 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ginny Braman | Concert Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Adelaide | South Australia | 5000 | Australia |
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| CTP-730, 60 mg | Experimental | Oral Suspension, once daily. |
|
| Placebo for CTP-730 | Drug |
|