A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Dose Block-randomized, Double-blind, Placebo Controlled, Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of DWP10292 and Ursodeoxycholic Acid in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWP10292
* Drug: DWP10292 Placebo
* Drug: Ursodeoxycholic acid (UDCA)
* Drug: UDCA Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints Healthy adult male subjects aged 19 to 45 years The subject has a Body weight ≥ 60 kg and < 90 kg and Body Mass Index(BMI) ≥ 18.5 kg/m2 and < 27.0 kg/m2 A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently) Exclusion Criteria: A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse A subject who shows vital signs with the number of systolic blood pressure of ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg A subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) or received a blood transfusion within last 1 month Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial) Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP10292<br>Drug: DWP10292 DWP10292 tablets, oral administration, multiple administration Arms: DWP10292 | Drug: DWP10292<br>* Drug: DWP10292 tablets, oral administration, multiple administration<br>|
| Placebo Comparator: DWP10292 Placebo<br>Drug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo | Drug: DWP10292 Placebo<br>* Placebo tablets, oral administration, multiple administrations<br>|
| Experimental: Ursodeoxycholic acid (UDCA)<br>Drug: Ursodeoxycholic acid (UDCA) UDCA tablets, oral administration, multiple administrations Arms: Ursodeoxycholic acid (UDCA) | Drug: Ursodeoxycholic acid (UDCA)<br>* Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration<br>|
| Placebo Comparator: Ursodeoxycholic acid (UDCA) Placebo<br>Drug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo | Drug: UDCA Placebo<br>* Placebo tablets, oral administration, multiple administrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |