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This study is being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD cohort 1 | Experimental | Single ascending dose (SAD) cohort 1 will participate in three dosing periods separated by 2 weeks. Eight subjects will be enrolled, 6 will receive RX-10001 and 2 will receive vehicle control. The starting dose will be 300 mg. Subsequent doses will be determined by the pk and safety data from previous cohorts. |
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| SAD cohort 2 | Experimental | SAD cohort 2 will participate in three dosing periods separated by 2 weeks. Eight subjects will be enrolled, 6 will receive RX-10001 and 2 will receive vehicle control. The doses to be administered will be determined by the pk and safety data from previous cohorts. |
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| MAD cohort 1 | Experimental | Multiple ascending dose (MAD) cohort 1 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous SAD cohorts. |
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| MAD cohort 2 | Experimental | MAD cohort 2 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohort. |
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| MAD cohort 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RX-10001 | Drug | RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability following single and multiple ascending oral doses as assessed by adverse events, vital signs, 12-lead ECG, clinical laboratory and physical exam. | 1 and 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pk and pharmacodynamics after single and multiple ascending doses | 1 and 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renger Tiessen, MD PhD | PRA Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Zuidlaren | 9471 GP | Netherlands |
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MAD cohort 3 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohorts. |
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| MAD cohort 4 | Experimental | MAD cohort 4 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohort. |
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