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This is a randomized, placebo-controlled, crossover study of Trans Sodium Crocetinate (TSC) in healthy volunteers, age 18-40 (inclusive), exercising at altitude. The primary objective is to determine the effect of (TSC) on partial pressure of oxygen (PaO2) and maximal oxygen consumption (VO2 max); the secondary objective is to assess the effect of TSC on oxygen saturation (SpO2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg/kg Trans Sodium Crocetinate | Experimental | Subjects will receive a single IV bolus dose of 0.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control. |
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| 1.5 mg/kg Trans Sodium Crocetinate | Experimental | Subjects will receive a single IV bolus dose of 1.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control. |
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| 2.5 mg/kg Trans Sodium Crocetinate | Experimental | Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans Sodium Crocetinate | Drug | Single IV bolus |
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| Measure | Description | Time Frame |
|---|---|---|
| Sequence matched median PaO2 per dose cohort comparing TSC vs PBO | Comparison of partial pressure of oxygen (PaO2) at altitude between control and experimental exposures | Up to 10 ± 1 minutes after final VO2 max |
| Sequence matched median VO2 per dose cohort comparing TSC vs PBO | Comparison of maximal oxygen consumption (VO2 max) at altitude between control and experimental exposures | Up to 33 minutes (achievement of peak wattage) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of TSC on Median Oxygen Saturation | Comparison of oxygen saturation (SpO2) between the control and experimental exposures | Up to 33 minutes (achievement of peak wattage) |
| Effect of TSC on Median Serum Lactate Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 22710 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 28, 2023 | |
| Reset | Dec 1, 2023 |
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Comparison of lactate between the control and experimental exposures
| Up to 33 minutes (achievement of peak wattage) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 28, 2023 | Dec 1, 2023 |
| ID | Term |
|---|---|
| C487773 | trans-sodium crocetinate |
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