Clinical Pharmacology Study of MP-424

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01766167

Enrollment

Registered

2013-01-11

Start date

2013-02-28

Completion date

2013-04-30

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Genotype 2

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.

Interventions

DRUGMP-424

Low

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026