Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers

Study Overview
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Brief Summary
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This study is a phase I clinical trial for evaluating the pharmacokinetics and safety/tolerability of DA-7218 in healthy male volunteers.

Official Title
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A Block-randomized, Double-blind, Placebo-controlled, Single-dose, Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: DA-7218
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male Korean 19-45 years Body weight:55-90kg, BMI:18.0-27.0 Exclusion Criteria: Present condition or history of any clinically significant disease Clinical evidence or history of GI disease or history of GI surgery History of hypersensitivities, including drug allergies AST (SGOT) or ALT (SGPT) > 1.5 times the upper normal limit Systolic blood pressure : <100 mmHg or >160 mmHg Diastolic blood pressure : <60 mmHg or >100 mmHg Drug abuse within 2 months, or a positive reaction to an abusive drug or cotinine Taken any ETC or herbal supplement within 2 weeks or any OTC or vitamin supplement within 1 week Participation in and administration of IP of another clinical trial within 2 months Donation of whole blood within 2 months, or blood components within 1 month, or receipt of blood transfusion within 1 month Consumption of more than 21 units of alcohol/week or inability to abstain from drinking during the study period Smoking within 3 months Taking caffeine- or grapefruit-containing products within 3 days Plan to be pregnant, or not to use an appropriate method of contraception

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [Group 1] DA-7218<br>200mg, By mouth or orally (PO) & intravenous(IV) administration | Drug: DA-7218<br> <br> |
| Placebo Comparator: [Group 1] Placebo<br>Placebo, By mouth or orally (PO) & intravenous(IV) administration | Drug: Placebo<br> <br> |
| Experimental: [Group 2] DA-7218<br>400mg, By mouth or orally (PO) administration | Drug: DA-7218<br> <br> |
| Placebo Comparator: [Group 2] Placebo<br>Placebo, By mouth or orally (PO) administration | Drug: Placebo<br> <br> |
| Experimental: [Group 3] DA-7218<br>600mg, By mouth or orally (PO) administration | Drug: DA-7218<br> <br> |
| Placebo Comparator: [Group 3] Placebo<br>Placebo, By mouth or orally (PO) administration | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast | Area under the concentration-time curve from time zero to the last quantifiable concentration by linear trapezoidal method | 72 hours | 
| Cmax |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1) |  | 72 hours |