Skip to main content
OpenTrials
Completed

NCT Number: NCT01766167

Clinical Pharmacology Study of MP-424

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MP-424

Drug

Low

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.