Clinical Pharmacology Study of MP-424

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766167
• Other study ID #: MP-424-K01
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2013
• Last updated: January 25, 2017
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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