Clinical Pharmacology Study of MP-424

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

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