Healthy Male VolunteersPhase 1NCT03089112

Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

A Phase 1 study testing HGP1607, HGP1501 and HGP1607+HGP1501 in people with Healthy Male Volunteers, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers Read more about this study

Who is it for?: Ages 19 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Volunteers
What is being tested?: HGP1607, HGP1501 and HGP1607+HGP1501
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: 31 Mar 2017to 16 Jun 2017
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 19 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

1.age 19~40 years
2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2
3.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Who cannot join

Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
Subjects who judged ineligible by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul Asan Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

Conditions: Healthy Male Volunteers
Being tested: HGP1607, HGP1501, HGP1607+HGP1501

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HGP1607Drug
Take it once per period
HGP1501Drug
Take it once per period
HGP1607+HGP1501Drug
Take it once per period

Study groups in NCT03089112
Study group	Role	What they receive
Seguence 1	Experimental	Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501 Receives: Drug: HGP1607; Drug: HGP1501; Drug: HGP1607+HGP1501
Seguence 2	Experimental	Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501 Receives: Drug: HGP1607; Drug: HGP1501; Drug: HGP1607+HGP1501
Seguence 3	Experimental	Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501 Receives: Drug: HGP1607; Drug: HGP1501; Drug: HGP1607+HGP1501
Seguence 4	Experimental	Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607 Receives: Drug: HGP1607; Drug: HGP1501; Drug: HGP1607+HGP1501
Seguence 5	Experimental	Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501 Receives: Drug: HGP1607; Drug: HGP1501; Drug: HGP1607+HGP1501
Seguence 6	Experimental	Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607 Receives: Drug: HGP1607; Drug: HGP1501; Drug: HGP1607+HGP1501

What is being measured

The primary outcome is the main question the study is designed to answer.

AUClast of HGP1607
Measured: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Cmax of HGP1607
Measured: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
baseline corrected AUClast of HGP1501
Measured: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Cmax of HGP1501
Measured: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Secondary outcomes (8)

AUCinf of HGP1607
Measured: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Tmax of HGP1607
Measured: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
T1/2 of HGP1607
Measured: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
AUClast of HGP1501
Measured: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Cmax of HGP1501
Measured: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected AUCinf of HGP1501
Measured: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Tmax of HGP1501
Measured: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected T1/2 of HGP1501
Measured: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 201716 Jun 2017

First posted24 Mar 2017
Study start31 Mar 2017
Primary completion28 May 2017
Study completion16 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Male 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: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03089112
Sponsor's protocol ID: HM-BAVI-101
Status last verified: Nov 2022
First submitted: 20 Mar 2017
Last updated: 10 Nov 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Male Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT03089112
Acronym / sponsor ID: HM-BAVI-101
Conditions: Healthy Male Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 31 Mar 2017 (actual)
Primary completion: 28 May 2017 (actual)
Study completion: 16 Jun 2017 (actual)
First posted: 24 Mar 2017 (actual)
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.

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Seguence 1	Experimental	Drug: HGP1607, Drug: HGP1501, Drug: HGP1607+HGP1501Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501
Seguence 2	Experimental	Drug: HGP1607, Drug: HGP1501, Drug: HGP1607+HGP1501Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501
Seguence 3	Experimental	Drug: HGP1607, Drug: HGP1501, Drug: HGP1607+HGP1501Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501
Seguence 4	Experimental	Drug: HGP1607, Drug: HGP1501, Drug: HGP1607+HGP1501Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607
Seguence 5	Experimental	Drug: HGP1607, Drug: HGP1501, Drug: HGP1607+HGP1501Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501
Seguence 6	Experimental	Drug: HGP1607, Drug: HGP1501, Drug: HGP1607+HGP1501Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607

Who may qualify

Ages: 19 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

1.age 19~40 years
2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2
3.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Key exclusion criteria (2 listed)

Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
Subjects who judged ineligible by the investigator

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
HGP1607Take it once per period	Drug	Seguence 1, Seguence 2, Seguence 3, Seguence 4, Seguence 5, Seguence 6
HGP1501Take it once per period	Drug	Seguence 1, Seguence 2, Seguence 3, Seguence 4, Seguence 5, Seguence 6
HGP1607+HGP1501Take it once per period	Drug	Seguence 1, Seguence 2, Seguence 3, Seguence 4, Seguence 5, Seguence 6

Primary outcome

AUClast of HGP1607
Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Cmax of HGP1607
Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
baseline corrected AUClast of HGP1501
Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Cmax of HGP1501
Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

8 secondary outcomes

AUCinf of HGP1607
Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Tmax of HGP1607
Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
T1/2 of HGP1607
Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
AUClast of HGP1501
Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Cmax of HGP1501
Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected AUCinf of HGP1501
Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Tmax of HGP1501
Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected T1/2 of HGP1501
Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

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 10 Nov 2022.

Related trials for Healthy Male Volunteers

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 HGP1607, HGP1501 and HGP1607+HGP1501 in people with Healthy Male 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 2 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 10 Nov 2022. 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?

AUClast of HGP1607 (time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03089112.

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 10 Nov 2022.