Study Results
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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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2013-02-28
2013-04-30
Brief Summary
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* Pharmacokinetics of MP-424 after a single and multiple doses.
* Safety and tolerability of single and multiple doses of MP-424.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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MP-424
MP-424
Low
MP-424
Middle
MP-424
High
MP-424
Multiple
Interventions
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MP-424
Low
MP-424
Middle
MP-424
High
MP-424
Multiple
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
55 Years
MALE
Yes
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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MP-424-K01
Identifier Type: -
Identifier Source: org_study_id
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