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Clinical Pharmacology Study of MP-424

This study has been completed.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation Identifier:
First received: January 6, 2013
Last updated: January 25, 2017
Last verified: April 2013

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.

Condition Intervention Phase
Chronic Hepatitis C
Drug: MP-424
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers [ Time Frame: up to 1 week ]
  • Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers [ Time Frame: up to 2 week ]

Enrollment: 26
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-424 Drug: MP-424
Drug: MP-424
Drug: MP-424
Drug: MP-424


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01766167

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT01766167     History of Changes
Other Study ID Numbers: MP-424-K01
Study First Received: January 6, 2013
Last Updated: January 25, 2017

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Genotype 2

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases processed this record on May 25, 2017