Clinical Pharmacology Study of MP-424

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01766167
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: MP-424 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)
Study Start Date : February 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: MP-424 Drug: MP-424
Drug: MP-424
Drug: MP-424
Drug: MP-424

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT01766167     History of Changes
Other Study ID Numbers: MP-424-K01
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: April 2013

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