Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Characteristics of HM61713 Tablet in Healthy Korean, Japanese and Caucasian

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01894399

Enrollment

Registered

2013-07-10

Start date

2013-09-30

Completion date

2013-11-30

Last updated

2016-12-15

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

Conditions

Healthy Volunteers

Keywords

HM61713, pharmacokinetics, Phase I, healthy, olmutinib

Brief summary

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.

Detailed 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

Interventions

DRUGHM61713

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Tmax of HM61713 and metabolites	0-48 hrs
Maximum plasma concentration (Cmax) of HM61713 and metabolites	0-48 hrs
Area under the plasma concentration time curve from zero to infinity (AUC) of HM61713 and metabolites	0-48 hrs
Mean residence time (MRT) of HM61713 and metabolites	0-48 hrs
Terminal half life (t1/2) of HM61713 and metabolites	0-48 hrs
The apparent plasma clearance (CL/F) of HM61713 and metabolites	0-48 hrs

Secondary

Measure	Time frame
Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events.	7 days after the investigational drug administration.

Countries

South Korea

Outcome results

None listed

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