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The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.
This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose escalation clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of DWP 10292 after oral administration in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP10292 | Experimental | Drug: DWP10292 DWP10292 tablets, oral administration, multiple administration Arms: DWP10292 |
|
| DWP10292 Placebo | Placebo Comparator | Drug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo |
|
| Ursodeoxycholic acid (UDCA) | Experimental | Drug: Ursodeoxycholic acid (UDCA) UDCA tablets, oral administration, multiple administrations Arms: Ursodeoxycholic acid (UDCA) |
|
| Ursodeoxycholic acid (UDCA) Placebo | Placebo Comparator | Drug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP10292 | Drug | Drug: DWP10292 tablets, oral administration, multiple administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pharmacokinetics | Peak Plasma Concentration (Cmax) | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |
| Composite of Pharmacokinetics | Area under the plasma concentration versus time curve (AUC) | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |
| Composite of Pharmacokinetics | Mean residence time (MRT) | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |
| Composite of Pharmacokinetics | Accumulation index | Multiple blood sample will be collected for 24 hours after last dosing in each of the periods |
| Measure | Description | Time Frame |
|---|---|---|
| [Safety & tolerability] Incidence of adverse events related with drug | Adverse events, Physical exam, Vital sign, laboratory (CBC, chemistry, U/A etc) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| DWP10292 Placebo |
| Drug |
Placebo tablets, oral administration, multiple administrations |
|
| Ursodeoxycholic acid (UDCA) | Drug | Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration |
|
| UDCA Placebo | Drug | Placebo tablets, oral administration, multiple administrations |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |