Clinical Pharmacology Study of MP-424

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01766167
First received: January 6, 2013
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers [ Time Frame: up to 2 week ] [ Designated as safety issue: Yes ]

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
Low
Drug: MP-424
Middle
Drug: MP-424
High
Drug: MP-424
Multiple

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766167

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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01766167     History of Changes
Other Study ID Numbers: MP-424-K01
Study First Received: January 6, 2013
Last Updated: April 2, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Genotype 2

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 28, 2014