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This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTP-730 Low Dose or Matching Placebo | Experimental | Capsule, once daily. |
|
| CTP-730 Mid Dose or Matching Placebo | Experimental | Capsule, once daily |
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| CTP-730 High Dose or Matching Placebo | Experimental | Capsule, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-730 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Profile | The primary pharmacokinetics parameters of interest will be time to attainment of steady state, and Cmax, Tmax, AUC0-24hr, AUClast and AUCinf at steady state | 96 hours |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Adverse events categorized by body system and MedDRA term | 24 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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| Placebo for CTP-730 |
| Drug |
|