Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

NCT01894399 | Completed Phase 1

• 1 other identifier: HM-EMSI-102
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

HM61713; pharmacokinetics; Phase I; healthy; olmutinib

Outcome Measures

Primary Outcomes (6)

• 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

• Tmax 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

• Mean residence time (MRT) of HM61713 and metabolites

  0-48 hrs

Secondary Outcomes (1)

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

  7 days after the investigational drug administration.

Study Arms (7)

Cohort 1

EXPERIMENTAL

100 mg HM61713 single dose in Korean

Drug: HM61713

Cohort 2

EXPERIMENTAL

200 mg HM61713 single dose in Korean

Drug: HM61713

Cohort 3

EXPERIMENTAL

300 mg HM61713 single dose in Korean

Drug: HM61713

Cohort 4

EXPERIMENTAL

200 mg HM61713 single dose in Japanese

Drug: HM61713

Cohort 5

EXPERIMENTAL

300 mg HM61713 single dose in Japanese

Drug: HM61713

Cohort 6

EXPERIMENTAL

200 mg HM61713 single dose in Caucasian

Drug: HM61713

Cohort 7

EXPERIMENTAL

300 mg HM61713 single dose in Caucasian

Drug: HM61713

Interventions

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

Also known as: Olmutinib

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Research Site

Seoul, South Korea

Location

MeSH Terms

Interventions

olmutinib

Study Officials

• In-Jin Jang, MD PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

KR (1)