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Completed

NCT Number: NCT01894399

Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM61713

Drug

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 names: Olmutinib

Primary outcomes

  1. Maximum plasma concentration (Cmax) of HM61713 and metabolites

    Time frame: 0-48 hrs

  2. Area under the plasma concentration time curve from zero to infinity (AUC) of HM61713 and metabolites

    Time frame: 0-48 hrs

  3. Tmax of HM61713 and metabolites

    Time frame: 0-48 hrs

  4. Terminal half life (t1/2) of HM61713 and metabolites

    Time frame: 0-48 hrs

  5. The apparent plasma clearance (CL/F) of HM61713 and metabolites

    Time frame: 0-48 hrs

  6. Mean residence time (MRT) of HM61713 and metabolites

    Time frame: 0-48 hrs

Secondary outcomes

  1. Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events.

    Time frame: 7 days after the investigational drug administration.

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2013
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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