Back to resultsClinical Pharmacology Study of MP-424
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MP-424
MP-424
MP-424
MP-424
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Hepatitis C focused on measuring Genotype 2
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MP-424
Arm Description
Outcomes
Primary Outcome Measures
MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers
Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers
Secondary Outcome Measures
Full Information
NCT ID
NCT01766167
First Posted
January 6, 2013
Last Updated
January 25, 2017
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01766167
Brief Title
Clinical Pharmacology Study of MP-424
Official Title
Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Genotype 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MP-424
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MP-424
Intervention Description
Low
Intervention Type
Drug
Intervention Name(s)
MP-424
Intervention Description
Middle
Intervention Type
Drug
Intervention Name(s)
MP-424
Intervention Description
High
Intervention Type
Drug
Intervention Name(s)
MP-424
Intervention Description
Multiple
Primary Outcome Measure Information:
Title
MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers
Time Frame
up to 1 week
Title
Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers
Time Frame
up to 2 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, M.D.
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Pharmacology Study of MP-424
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