Clinical Pharmacology Study of MP-424

NCT ID: NCT01766167

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-04-30

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.

Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MP-424

Group Type EXPERIMENTAL

MP-424

Intervention Type DRUG

Low

MP-424

Intervention Type DRUG

Middle

MP-424

Intervention Type DRUG

High

MP-424

Intervention Type DRUG

Multiple

Interventions

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MP-424

Low

Intervention Type DRUG

MP-424

Middle

Intervention Type DRUG

MP-424

High

Intervention Type DRUG

MP-424

Multiple

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kazuoki Kondo, M.D.

Role: STUDY_DIRECTOR

Mitsubishi Tanabe Pharma Corporation

Locations

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Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MP-424-K01

Identifier Type: -

Identifier Source: org_study_id

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