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This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).
In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-0120 Dose 1 | Experimental | D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation |
|
| D-0120 Dose 2 | Experimental | D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation |
|
| D-0120 Dose 3 | Experimental | D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation |
|
| D-0120 Dose 4 | Experimental | D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation |
|
| D-0120 Dose 5 | Experimental | D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-0120 | Drug | oral, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic: area under the plasma concentration versus time curve (AUC) | AUC: area under the plasma concentration versus time curve for D-0120 | Day-1 through 3 |
| Pharmacokinetic: maximum plasma drug concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Coleman, MD | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Daytona Beach Clinical Research Unit | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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Cmax: maximum plasma drug concentration of D-0120
| Day-1 through 3 |
| Pharmacokinetic: Time to reach the Cmax (Tmax) | Tmax: Time to reach the Cmax of D-0120 | Day-1 through 3 |
| Pharmacokinetic: Apparent terminal half-life (t1/2) | t1/2: apparent terminal half-life of D-0120 | Day-1 through 3 |
| Pharmacokinetic: Apparent oral clearance (CL/F) | CL/F: Apparent oral clearance of D-0120 | Day-1 through 3 |
| Pharmacokinetic: Apparent volume of distribution (Vz/F) | Vz/F: Apparent volume of distribution of D-0120 | Day-1 through 3 |
| PD profile of D-0120 from plasma and urine | Profile in terms of Serum uric acid and creatinine; Urine uric acid and creatinine. These parameters will be combined to report fractional excretion of uric acid (FEUa %) | Day-1 through 3 |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |