Clinical Pharmacology Study of MP-424
- Registration Number
- NCT01766167
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MP-424 MP-424 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method