Clinical Pharmacology Study of MP-424

Study Overview
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Brief Summary
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To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets: Pharmacokinetics of MP-424 after a single and multiple doses. Safety and tolerability of single and multiple doses of MP-424.

Official Title
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Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: MP-424
* Drug: MP-424
* Drug: MP-424
* Drug: MP-424


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Korean healthy male volunteers aged 20 to 55 years Exclusion Criteria: Subjects with a BMI of <18.5 or >25.0, or body weight of <50kg at prior examination Subjects who have had surgery that is known to affect gastrointestinal absorption of drugs (except for appendectomy and hernia surgery) Subjects who have had any evidence of cardiac disease at prior examination or who have a previous history of cardiac disease Subjects who are positive for HBs antigen, serologic tests for syphilis, HCV antibody, or HIV antibody at prior examination Subjects who have experienced symptoms of alcohol abuse or excessive alcohol ingestion Subjects who test positive on urinalysis for drug use (amphetamine, benzodiazepine, barbiturates, cannabinoid, cocaine, opiates, and methadone) at prior examination Subjects who do not agree to use a physical contraceptive method during the study period Subjects who do not agree to use contraceptive methods for 90 days after final administration of the study drug Subjects who have consumed grapefruit, Seville orange, star fruit, cranberry, or any processed food containing these fruits within 7 days before the commencement of study drug administration Subjects who have consumed health foods containing St John's Wort within 2 weeks before study drug administration

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MP-424<br> | Drug: MP-424<br>* Low<br>Drug: MP-424<br>* Middle<br>Drug: MP-424<br>* High<br>Drug: MP-424<br>* Multiple<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers |  | up to 1 week | 
| Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers |  | up to 2 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genotype 2