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Double Blinded Healthy Volunteer study evaluating D-2570 against placebo in various doses.
Double blind study evaluating the safety, tolerability and PK data of D-2570/placebo in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 D-2570/Placebo | Experimental |
| |
| Cohort 2 D-2570/Placebo | Experimental |
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| Cohort 3 D-2570/Placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-2570 | Drug | D-2570 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Incidence of adverse events | From Informed Consent through study completion, an average of 48 days |
| Result of Pharmacokinetic endpoint | Tmax | From Randomization through study completion, an average of 20 days |
| Result of Pharmacokinetic endpoint | Cmax | From Randomization through study completion, an average of 20 days |
| Result of Pharmacokinetic endpoint | t1/2 | From Randomization through study completion, an average of 20 days |
| Result of Pharmacokinetic endpoint | MRT | From Randomization through study completion, an average of 20 days |
| Result of Pharmacokinetic endpoint | AUC0-∞ | From Randomization through study completion, an average of 20 days. |
| Result of Pharmacokinetic endpoint | AUC0-t | From Randomization through study completion, an average of 20 days |
| Result of Pharmacokinetic endpoint | CL/F | From Randomization through study completion, an average of 20 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron | Baltimore | Maryland | 21201 | United States |
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| Placebo | Drug | Placebo |
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| Result of Pharmacokinetic endpoint | Vz/F | From Randomization through study completion, an average of 20 days |