Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects
NCT ID: NCT01894399
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2013-09-30
2013-11-30
Brief Summary
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* Open, escalating single-dose design.
* 7 ascending dose cohorts
* In each cohorts, subjects will receive a single dose of HM61713.
* Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.
Detailed Description
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• To assess the PK characteristics of HM61713 and metabolites in healthy male volunteers
Secondary objectives
* To assess the safety and tolerability of HM61713 tablet in healthy male subjects.
* To assess the food effect on PK characteristics of HM61713 tablet in healthy male subjects.
* To assess the ethnic differences of PK characteristics of HM61713 (Korean, Japanese, Caucasian)
* To investigate genotype of drug metabolism.transport that affect PK characteristics of HM61713
* To investigate the change of endogenous metabolic markers after administration of HM61713
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
100 mg HM61713 single dose in Korean
HM61713
Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Cohort 2
200 mg HM61713 single dose in Korean
HM61713
Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Cohort 3
300 mg HM61713 single dose in Korean
HM61713
Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Cohort 4
200 mg HM61713 single dose in Japanese
HM61713
Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Cohort 5
300 mg HM61713 single dose in Japanese
HM61713
Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Cohort 6
200 mg HM61713 single dose in Caucasian
HM61713
Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Cohort 7
300 mg HM61713 single dose in Caucasian
HM61713
Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Interventions
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HM61713
Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* BMI of \>18.5kg/m2 and \<28kg/m2 subject
Exclusion Criteria
* Use of any medication within 1 weeks prior to Day 1
* Has a severe medical history of hypersensitivity to drug
* Participation in another clinical study within 8 weeks days prior to start of study drug administration
20 Years
45 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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In-Jin Jang, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Research Site
Seoul, , South Korea
Countries
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Other Identifiers
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HM-EMSI-102
Identifier Type: -
Identifier Source: org_study_id