Benign Prostatic HyperplasiaPhase 1CKD-397NCT02645890

Study to Compare the Safety and Pharmacokinetics of CKD-397

A Phase 1 study testing CKD-397 and TD+TM in people with Benign Prostatic Hyperplasia, run by Chong Kun Dang Pharmaceutical 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

The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers. Read more about this study

Who is it for?: Ages 19 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: CKD-397 and TD+TM
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSouth Korea
Study dates: Nov 2015to Dec 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 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

More than 19 years in Healthy male volunteer
Body weight ≥ 55kg and in the range of calculated BMI 17.5 to 30.5kg/m2
Subject who signed on an informed consent form willingly

Who cannot join

Clinically significant disease with hematological, nephrological, respiratory, gastrointestinal, urogenital, cardiovascular, psychiatric, neurologic system and allergic disease (except for non-symptom seasonal allergy)
Gastrointestinal disease(esophageal achalasia, esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for appendectomy or herniotomy)
Aspartate aminotransferase, Alanine aminotransferase > 2 X upper limit of normal range or eGFR which is calculated by MDRD(Modification of diet in renal disease) < 60mL/min/1.73m2
Continuously taking excessive alcohol(>210g/week) within 6 months before screening
Have received any other investigational drug within 3 months prior to the first dosing
Sitting systolic blood pressure ≤ 100mmHg or ≥ 150mmHg, sitting diastolic blood pressure ≤ 60mmHg or ≥ 100mmHg

Show all 21Show fewer

Subject with orthostatic hypotension
The history of drug abuse or drug abuse showed a positive for urine drug test
Subject who takes inducers or inhibitors of drug metabolizing enzyme within 30 days
Cigarette ≥ 20 cigarettes a day for recent 3 months and Subject who cannot stop smoking during clinical trial participation
Subject who takes ethical drug or herbal medicine within 2 weeks or over-the-counter drug or vitamins within 1 week
Whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing
Subject who can increase risk due to clinical test and administration of drugs or has severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
Subject with taking any forms of organic nitrate periodically and/or intermittently.
Subject with known hereditary degenerative retinal disease including retinitis pigmentosa.
Subject with serious history of hypersensitivity to investigational product (including Tadalafil and Tamsulosin) and other medicine (aspirin, antibiotics and so on)
Subject who lost sight of one eye by non-arteritic anterior ischemic optic neuropathy (NAION, non-arteritic anterior ischemic optic neuropathy).
Subject with genetic problems such as galactose intolerance, fructose intolerance, lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
Subject who planned pregnancy during clinical trial and doesn't use trustworthy contraception
Subjects who is not able to comply with guidelines described in the protocol.
An impossible one who participants in clinical trials by investigator's decision including laboratory test result or another reason

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Dong A University Hospital
Seo-gu, Busan, 49201

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Profiles of CKD-397 in Healthy Male Subjects

The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers.

Read the detailed description

A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects

Conditions: Benign Prostatic Hyperplasia
Being tested: CKD-397, TD+TM
Keywords: Benign Prostatic Hyperplasia, Healthy Male Volunteer, Tamsulosin, Tadalafil
Medical subject headings: Prostatic Hyperplasia

What participants receive

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

CKD-397Drug
Also called Arm A
Arm A:Tamsulosin/ Tadalafil Fixed dose combination
TD+TMDrug
Also called Arm B
Arm B: Tamsulosin/ Tadalafil Coadministration

Study groups in NCT02645890
Study group	Role	What they receive
CKD-397	Active comparator	Tadalafil/ Tamsulosin Fixed dose combination Receives: Drug: CKD-397
TD+TM	Experimental	Tadalafil/ Tamsulosin Coadministration Receives: Drug: TD+TM

What is being measured

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

AUC0-t of Tadalafil/ Tamsulosin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Secondary outcomes (6)

Cmax of Tadalafil/ Tamsulosin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
AUCinf of Tadalafil/ Tamsulosin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Tmax of Tadalafil/ Tamsulosin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
t1/2 of Tadalafil/ Tamsulosin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
CL/F of Tadalafil/ Tamsulosin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Vd/F of Tadalafil/ Tamsulosin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Timeline

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

Nov 2015Dec 2015

First posted5 Jan 2016 (estimated)
Study startNov 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by Chong Kun Dang PharmaceuticalThe 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02645890
Sponsor's protocol ID: 150BPH15022
Acronym: CKD-397
Status last verified: Jan 2016
First submitted: 21 Dec 2015
Last updated: 12 Jan 2016
Results posted: No
Data monitoring committee: 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 Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Profiles of CKD-397 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02645890
Acronym / sponsor ID: CKD-397 / 150BPH15022
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia, Healthy Male Volunteer, Tamsulosin, Tadalafil
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 5 Jan 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.

The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers.

Detailed description

A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects

Study design

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

Arm	Type	Receives
CKD-397	Active comparator	Drug: CKD-397Tadalafil/ Tamsulosin Fixed dose combination
TD+TM	Experimental	Drug: TD+TMTadalafil/ Tamsulosin Coadministration

Who may qualify

Ages: 19 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

More than 19 years in Healthy male volunteer
Body weight ≥ 55kg and in the range of calculated BMI 17.5 to 30.5kg/m2
Subject who signed on an informed consent form willingly

Key exclusion criteria (21 listed)

Clinically significant disease with hematological, nephrological, respiratory, gastrointestinal, urogenital, cardiovascular, psychiatric, neurologic system and allergic disease (except for non-symptom seasonal allergy)
Gastrointestinal disease(esophageal achalasia, esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for appendectomy or herniotomy)
Aspartate aminotransferase, Alanine aminotransferase > 2 X upper limit of normal range or eGFR which is calculated by MDRD(Modification of diet in renal disease) < 60mL/min/1.73m2
Continuously taking excessive alcohol(>210g/week) within 6 months before screening
Have received any other investigational drug within 3 months prior to the first dosing

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
CKD-397Also: Arm AArm A:Tamsulosin/ Tadalafil Fixed dose combination	Drug	CKD-397
TD+TMAlso: Arm BArm B: Tamsulosin/ Tadalafil Coadministration	Drug	TD+TM

Primary outcome

AUC0-t of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

6 secondary outcomes

Cmax of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
AUCinf of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Tmax of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
t1/2 of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
CL/F of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Vd/F of Tadalafil/ Tamsulosin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

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 12 Jan 2016.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

Min Kyu Park, MD, PhD principal investigator

9F, DongA University Hospital Department of clinical pharmacology, #26, Daechingongwon-ro, seo-gu, busan, 49201, KOREA

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 CKD-397 and TD+TM in people with Benign Prostatic Hyperplasia, run by Chong Kun Dang Pharmaceutical 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 21 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 12 Jan 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?

AUC0-t of Tadalafil/ Tamsulosin (time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours). 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 NCT02645890.

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 12 Jan 2016.