Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet

Study Overview
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Brief Summary
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The purposes of this study are to investigate the duration of P-glycoprotein inhibition after oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK tablet.

Official Title
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Clinical Trial to Investigate the Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet in Healthy Male Subjects : An Open, Parallel Dose Group Design

Conditions
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Healthy

Intervention / Treatment
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* Drug: HM30181AK 1mg
* Drug: HM30181AK 5mg
* Drug: HM30181AK 15mg
* Drug: HM30181AK 60mg
* Drug: Loperamide 2mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged 20 to 50 years at screening Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight Ideal body weight = (height cm - 100) x 0.9 Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial Exclusion Criteria: Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system. History of the gastrointestinal diseases which may affect the absorption of oral drugs (e.g., Crohn's disease) or gastrointestinal operations (excluding simple typhlotomy and hernia repair). The following results in laboratory test AST, ALT > 1.25 x upper limits of normal Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs History of drug allergy or other allergies which are clinically significant History of drug abuse or positive reaction for drug abuse in urine screening test Subjects who took prescription drugs or herbal medicines within 2 weeks prior to the first day of drug administration or OTC or vitamin preparations within 1 week prior to the first day of drug administration If the subjects meet other criteria, they could participate in the trial in the judgement of investigator.) Subjects who have participated in other clinical trial within 2 months prior to the first day of drug administration Whole blood donation within 2 months prior to the first day of drug administration or apheresis donation within 2 weeks prior to the first day of drug administration Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit drinking during clinical trial period Subject who are smoking over 10 cigar/day Subjects who eat food containing caffeine or grapefruit or drink alcohol in prohibited period Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1mg group<br>Administration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 | Drug: HM30181AK 1mg<br>* HM30181AK 1mg tablet<br>Drug: Loperamide 2mg<br>* Loperamide 2mg capsule<br>|
| Experimental: 5mg group<br>Administration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15 | Drug: HM30181AK 5mg<br>* HM30181AK 5mg tablet<br>Drug: Loperamide 2mg<br>* Loperamide 2mg capsule<br>|
| Experimental: 10mg group<br>Administration of HM30181AK 10mg(HM30181AK 5mg x 2tab)on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 | Drug: HM30181AK 5mg<br>* HM30181AK 5mg tablet<br>Drug: Loperamide 2mg<br>* Loperamide 2mg capsule<br>|
| Experimental: 15mg group<br>Administration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 | Drug: HM30181AK 15mg<br>* HM30181AK 15mg tablet<br>Drug: Loperamide 2mg<br>* Loperamide 2mg capsule<br>|
| Experimental: 60mg group<br>Administration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 | Drug: HM30181AK 60mg<br>* HM30181AK 60mg tablet<br>Drug: Loperamide 2mg<br>* Loperamide 2mg capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement. |  | Day 1 Day 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK |  | Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pgp inhibitor, P-glycoprotein inhibitor