A Single Dose Study of DWP10292 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 orally administrated DWP10292 in healthy male volunteers.

Official Title
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A Dose Block-randomized, Double-blind, Placebo Controlled, Single-dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of DWP10292 After Oral Administration in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWP10292
* Drug: 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 20 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 shows the following result in clinical laboratory test: AST,ALT>1.25 times of the upper limit of normal range QTc>430msec T.bil>1.25 times of the upper limit of normal range A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 8 weeks Subject who has taken other clinical or licensed medication from another clinical trial within an 8-week 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: 20 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Drug: Placebo tablets, oral administration, single administrations Arms: Placebo | Drug: Placebo<br>* Placebo tablets, oral administration, single administrations<br>|
| Experimental: DWP10292<br>Drug: DWP10292 tablets, oral administration, single administrations Arms: DWP10292 | Drug: DWP10292<br>* Drug: DWP10292 tablets, oral administration, single administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Pharmacokinetics | Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F | 0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) and Post study visit 216h (10d 0h) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety&tolerability | Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc) | 0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) Post study visit 216h (10d 0h) |