Clinical Pharmacology Study of MP-424

NCT01766167 | Completed Phase 1

• 1 other identifier: MP-424-K01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

Genotype 2

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

MP-424

EXPERIMENTAL

Drug: MP-424

Interventions

MP-424 DRUG

Low

MP-424

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Korean healthy male volunteers aged 20 to 55 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kazuoki Kondo, M.D.

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2013
• First Posted: January 11, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 26, 2017

Record last verified: 2013-04

Locations

KR (1)