Clinical Pharmacology Study of MP-424

Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: MP-424; Drug: MP-424; Drug: MP-424; Drug: MP-424

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MP-424	Drug: MP-424; Low; Drug: MP-424; Middle; Drug: MP-424; High; Drug: MP-424; Multiple

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Investigators: Study Director: Kazuoki Kondo, M.D., Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 6, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Genotype 2
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: MP-424-K01