Erectile DysfunctionPhase 1NCT02712411

Pharmacokinetics and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 in Healthy Male Volunteers

A Phase 1 study testing HCP1303, HGP1201 and HIP1402 in people with Erectile Dysfunction and Prostatic Hyperplasia, 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

To investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male volunteers Read more about this study

Who is it for?: Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Erectile Dysfunction, Prostatic Hyperplasia
What is being tested?: HCP1303, HGP1201 and HIP1402
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: Jul 2015to Sep 2015
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male volunteer, age 20~55 years
The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
Subject who has the ability and willingness to participate the whole period of trial

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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
History of relevant drug allergies or clinically significant hypersensitivity reaction.
Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower thatn 60mmHg or higher than 100mmHg
Subjects who judged ineligible by the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Yonsei University Health System, Severance Hospital
Seodaemun-Gu, Seoul, 03722

Other trials in South Korea

About this study

Official title: A Randomized, Open-Label, Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety After Administration of HCP1303 Capsule and Co-administration of HGP1201 Tablet, HIP1402 Capsule in Healthy Male Volunteers

To investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male volunteers

Read the detailed description

The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male volunteers

Conditions: Erectile Dysfunction, Prostatic Hyperplasia
Being tested: HCP1303, HGP1201, HIP1402
Medical subject headings: Erectile Dysfunction, Prostatic Hyperplasia

What participants receive

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

HCP1303Drug
HGP1201Drug
HIP1402Drug

Study groups in NCT02712411
Study group	Role	What they receive
Sequence 1	Experimental	T → R T : HCP1303 R : HGP1201 + HIP1402 Receives: Drug: HCP1303; Drug: HGP1201; Drug: HIP1402
Sequence 2	Experimental	R → T T : HCP1303 R : HGP1201 + HIP1402 Receives: Drug: HCP1303; Drug: HGP1201; Drug: HIP1402

What is being measured

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

AUClast
Measured: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
Cmax
Measured: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

Secondary outcomes (5)

AUCinf
Measured: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
tmax
Measured: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
t1/2
Measured: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
Cl/F
Measured: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
Vd/F
Measured: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

Timeline

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

Jul 2015Sep 2015

First posted18 Mar 2016 (estimated)
Study startJul 2015
Primary completionAug 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Erectile DysfunctionStudies 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: NCT02712411
Sponsor's protocol ID: HM-TASU-102
Status last verified: Feb 2016
First submitted: 24 Feb 2016
Last updated: 18 Mar 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: 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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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety After Administration of HCP1303 Capsule and Co-administration of HGP1201 Tablet, HIP1402 Capsule in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02712411
Acronym / sponsor ID: HM-TASU-102
Conditions: Erectile Dysfunction, Prostatic Hyperplasia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Aug 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 18 Mar 2016 (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.

To investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male volunteers

Detailed description

The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence 1	Experimental	Drug: HCP1303, Drug: HGP1201, Drug: HIP1402T → R T : HCP1303 R : HGP1201 + HIP1402
Sequence 2	Experimental	Drug: HCP1303, Drug: HGP1201, Drug: HIP1402R → T T : HCP1303 R : HGP1201 + HIP1402

Who may qualify

Ages: 19 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male volunteer, age 20~55 years
The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
Subject who has the ability and willingness to participate the whole period of trial

Key exclusion criteria (6 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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
History of relevant drug allergies or clinically significant hypersensitivity reaction.
Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower thatn 60mmHg or higher than 100mmHg

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
HCP1303	Drug	Sequence 1, Sequence 2
HGP1201	Drug	Sequence 1, Sequence 2
HIP1402	Drug	Sequence 1, Sequence 2

Primary outcome

AUClast
Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
Cmax
Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

5 secondary outcomes

AUCinf
Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
tmax
Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
t1/2
Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
Cl/F
Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose
Vd/F
Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

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 18 Mar 2016.
Individual participant dataSharing planned: No

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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.

Minsu Park, M.D., Ph.D. principal investigator

Yonsei University Health System, Severance 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 HCP1303, HGP1201 and HIP1402 in people with Erectile Dysfunction and Prostatic Hyperplasia, 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 4 inclusion and 6 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 18 Mar 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?

AUClast (time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose). The study lists 2 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 NCT02712411.

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 18 Mar 2016.