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Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

Hanmi Pharmaceutical logo

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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