Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

December 14, 2016 updated by: Hanmi Pharmaceutical Company Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
100 mg HM61713 single dose in Korean
Drug: 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 Names:
  • Olmutinib
Experimental: Cohort 2
200 mg HM61713 single dose in Korean
Drug: 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 Names:
  • Olmutinib
Experimental: Cohort 3
300 mg HM61713 single dose in Korean
Drug: 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 Names:
  • Olmutinib
Experimental: Cohort 4
200 mg HM61713 single dose in Japanese
Drug: 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 Names:
  • Olmutinib
Experimental: Cohort 5
300 mg HM61713 single dose in Japanese
Drug: 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 Names:
  • Olmutinib
Experimental: Cohort 6
200 mg HM61713 single dose in Caucasian
Drug: 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 Names:
  • Olmutinib
Experimental: Cohort 7
300 mg HM61713 single dose in Caucasian
Drug: 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 Names:
  • Olmutinib

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: In-Jin Jang, MD PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HM-EMSI-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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