Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

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Hanmi Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: HM61713

Study type

Interventional

Funder types

Industry

Identifiers

NCT01894399
HM-EMSI-102

Details and patient eligibility

About

Study Design 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.

Full description

Primary objectives • 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

Enrollment

59 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male volunteers, age between 20 and 45
  • 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 prescription medication within 2 weeks prior to Day 1
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

59 participants in 7 patient groups

Cohort 1
Experimental group
Description:
100 mg HM61713 single dose in Korean
Treatment:
Drug: HM61713
Cohort 2
Experimental group
Description:
200 mg HM61713 single dose in Korean
Treatment:
Drug: HM61713
Cohort 3
Experimental group
Description:
300 mg HM61713 single dose in Korean
Treatment:
Drug: HM61713
Cohort 4
Experimental group
Description:
200 mg HM61713 single dose in Japanese
Treatment:
Drug: HM61713
Cohort 5
Experimental group
Description:
300 mg HM61713 single dose in Japanese
Treatment:
Drug: HM61713
Cohort 6
Experimental group
Description:
200 mg HM61713 single dose in Caucasian
Treatment:
Drug: HM61713
Cohort 7
Experimental group
Description:
300 mg HM61713 single dose in Caucasian
Treatment:
Drug: HM61713

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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