Healthy VolunteersPhase 1NCT01894399
Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects
A Phase 1 study testing HM61713 in people with Healthy Volunteers, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HM61713
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy Volunteers
- Being tested
- HM61713
- Keywords
- HM61713, pharmacokinetics, Phase I, healthy, olmutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM61713Drug
Also called Olmutinib
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 group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 100 mg HM61713 single dose in Korean Receives: Drug: HM61713 |
| Cohort 2 | Experimental | 200 mg HM61713 single dose in Korean Receives: Drug: HM61713 |
| Cohort 3 | Experimental | 300 mg HM61713 single dose in Korean Receives: Drug: HM61713 |
| Cohort 4 | Experimental | 200 mg HM61713 single dose in Japanese Receives: Drug: HM61713 |
| Cohort 5 | Experimental | 300 mg HM61713 single dose in Japanese Receives: Drug: HM61713 |
| Cohort 6 | Experimental | 200 mg HM61713 single dose in Caucasian Receives: Drug: HM61713 |
| Cohort 7 | Experimental | 300 mg HM61713 single dose in Caucasian Receives: Drug: HM61713 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of HM61713 and metabolites
Measured: 0-48 hrs
Area under the plasma concentration time curve from zero to infinity (AUC) of HM61713 and metabolites
Measured: 0-48 hrs
Tmax of HM61713 and metabolites
Measured: 0-48 hrs
Terminal half life (t1/2) of HM61713 and metabolites
Measured: 0-48 hrs
The apparent plasma clearance (CL/F) of HM61713 and metabolites
Measured: 0-48 hrs
Mean residence time (MRT) of HM61713 and metabolites
Measured: 0-48 hrs
Secondary outcomes (1)
Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events.
Measured: 7 days after the investigational drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894399
- Sponsor's protocol ID
- HM-EMSI-102
- Status last verified
- Dec 2016
- First submitted
- 3 Jul 2013
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Characteristics of HM61713 Tablet in Healthy Korean, Japanese and Caucasian
- ClinicalTrials.gov ID
- NCT01894399
- Acronym / sponsor ID
- HM-EMSI-102
- Conditions
- Healthy Volunteers
- Keywords
- HM61713, pharmacokinetics, Phase I, healthy, olmutinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HM61713100 mg HM61713 single dose in Korean |
| Cohort 2 | Experimental | Drug: HM61713200 mg HM61713 single dose in Korean |
| Cohort 3 | Experimental | Drug: HM61713300 mg HM61713 single dose in Korean |
| Cohort 4 | Experimental | Drug: HM61713200 mg HM61713 single dose in Japanese |
| Cohort 5 | Experimental | Drug: HM61713300 mg HM61713 single dose in Japanese |
| Cohort 6 | Experimental | Drug: HM61713200 mg HM61713 single dose in Caucasian |
| Cohort 7 | Experimental | Drug: HM61713300 mg HM61713 single dose in Caucasian |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM61713Also: OlmutinibCohort 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 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Maximum plasma concentration (Cmax) of HM61713 and metabolites
Time frame: 0-48 hrs
Area under the plasma concentration time curve from zero to infinity (AUC) of HM61713 and metabolites
Time frame: 0-48 hrs
Tmax of HM61713 and metabolites
Time frame: 0-48 hrs
Terminal half life (t1/2) of HM61713 and metabolites
Time frame: 0-48 hrs
The apparent plasma clearance (CL/F) of HM61713 and metabolites
Time frame: 0-48 hrs
Mean residence time (MRT) of HM61713 and metabolites
Time frame: 0-48 hrs
1 secondary outcome
Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events.
Time frame: 7 days after the investigational drug administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang, MD PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM61713 in people with Healthy Volunteers, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) of HM61713 and metabolites (time frame: 0-48 hrs). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.