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This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Subjects will be randomized to a treatment sequence consisting of 4 treatment periods with a minimum 5-day washout between treatments. Subjects will receive each of the study treatments over the course of the study. Randomized subjects will receive the assigned study treatment as a single dose in the fasted state in the morning on Day 1 of each treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CR845 0.5 mcg/kg IV (Therapeutic Dose) | Experimental |
| |
| CR845 3 mcg/kg IV (Supratherapeutic Dose) | Experimental |
| |
| Placebo IV | Placebo Comparator |
| |
| Moxifloxacin 400 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CR845 0.5 mcg/kg IV | Drug | 0.5 mcg/kg IV CR845 |
|
| Measure | Description | Time Frame |
|---|---|---|
| QTc change from baseline following CR845 treatment. | Baseline, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTc with Bazett correction (QTcB). | Baseline, Day 1 | |
| Change from baseline in Heart Rate. | Baseline, Day 1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédérique Menzaghi, PhD | Cara Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cara Therapeutics Study Site | Dallas | Texas | 75247 | United States |
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| CR845 3 mcg/kg IV | Drug | 3 mcg/kg IV CR845 |
|
|
| Moxifloxacin 400 mg Oral Tablet | Drug | 400 mg Oral Moxifloxacin |
|
|
| Placebo | Other | IV Placebo as a bolus injection |
|
| ID | Term |
|---|---|
| C000657129 | difelikefalin |
| D000077266 | Moxifloxacin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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