Clinical Pharmacology Study of MP-424

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 1

Conditions

Chronic Hepatitis C

Treatments

Drug: MP-424

Study type

Interventional

Funder types

Industry

Identifiers

MP-424-K01

Details and patient eligibility

About

To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets:

Enrollment

26 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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