Clinical Pharmacology Study of MP-424

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 1

Conditions

Chronic Hepatitis C

Treatments

Drug: MP-424

Study type

Interventional

Funder types

Industry

Identifiers

NCT01766167
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: * Pharmacokinetics of MP-424 after a single and multiple doses. * Safety and tolerability of single and multiple doses of MP-424.

Enrollment

26 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

MP-424
Experimental group
Treatment:
Drug: MP-424

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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