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This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-0120 Dose Ascending Cohorts 1-4 | Active Comparator | D-0120 dose daily for up to 7 days. |
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| Placebo Dose Ascending Cohorts 1-4 | Placebo Comparator | Placebo dose daily for up to 7 days |
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| D-0120/Uric Acid Lowering Agent Cohort 6 | Experimental | D-0120 in combination with a uric acid lowering agent for up to 7 days of combination therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-0120 | Drug | Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with treatment related adverse events as assessed | Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs | Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to observed Cmax (Tmax)for D-0120 | Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax | Timeframe: Day 1-Day7 |
| Area under the plasma concentration-time curve (AUC) for D-0120 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health | Miami | Florida | 33163 | United States |
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Double Blind, placebo controlled
| Placebo oral tablet | Drug | Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo |
|
Blood samples will be collected to assess plasma concentration of D-0120 at a series of timepoints to derive AUC
| Day 1-Day 7 |
| Maximum Observed Plasma Concentration (Cmax) of D-0120 | Blood samples will be collect to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax | Day 1-Day 7 |