Benign Prostatic HyperplasiaPhase 1NCT03240939
Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil
A Phase 1 study testing Dutasteride 0.5 mg, Tadalafil 5 mg and YY-201 in people with Benign Prostatic Hyperplasia, run by Yuyu Pharma, Inc. at 1 site in South Korea.
Trial summary
A randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil administered in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Dutasteride 0.5 mg, Tadalafil 5 mg and YY-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Mar 2017to 10 Oct 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19 to 45 years
- BMI score 19 kg/m2 to 28 kg/m2
- SBP < 140 mmHg and ≤ 90 mmHg or DBP < 90 mmHg and ≥ 50 mmHg
- Eligible according to the laboratory results of hematology, blood chemistry and urinalysis
- Voluntarily signed the informed consent form
Who cannot join
- Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months
- History of hypersensitivity
- history of Cardiovascular disease
- History of degenerative Retina disease
- Lactose intolerance
- Medical history of vision loss
Show all 17Show fewer
- Clinically significant disorders of allergy, drug hypersensitivity reaction, hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system
- Donated whole blood (transfusion, apheresis etc..) within 60 days
- Participated and administered the investigational products in other clinical trial within 90 days
- Taking drugs which may affect Clinical trial within 30 days
- Smoked more than 10 cigarettes a day for past 30 days
- Excessive alcohol consumption (> 3 units/week, 1 unit)
- Taking food which may affect Clinical trial within 7 days
- Positive result from Urinary test
- Positive result from Serum test
- Clinically significant disorders result from Electrocardiography test
- Not eligible due to investigator's judgments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil Administered in Healthy Male Volunteer
A randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil administered in healthy male volunteers
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Dutasteride 0.5 mg, Tadalafil 5 mg, YY-201
- Keywords
- Dutasteride, 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.
Dutasteride 0.5 mgDrug
single dose
Tadalafil 5 mgDrug
single dose
YY-201Drug
single dose
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride&Tadalafil | Active comparator | Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose Receives: Drug: Dutasteride 0.5 mg; Drug: Tadalafil 5 mg |
| YY-201 | Experimental | YY-201 capsule, singe dose Receives: Drug: YY-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
"Peak Plasma Concentration" of Dutasteride, tadalafil
Measured: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
Secondary outcomes (3)
Tmax
Time at which the maximum concentration of Dutasteride, Tadalafil
Measured: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
t1/2β
half-life
Measured: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
AUCinf
area under the plasma concentration versus time curve of Dutasteride, Tadalafil
Measured: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start27 Mar 2017
- Primary completion7 Jul 2017
- Study completion10 Oct 2017
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuyu Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyeong-Seok Lim, M.D.,Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240939
- Sponsor's protocol ID
- YY-201_PK
- Status last verified
- May 2017
- First submitted
- 24 Apr 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil Administered in Healthy Male Volunteer
- ClinicalTrials.gov ID
- NCT03240939
- Acronym / sponsor ID
- YY-201_PK
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Dutasteride, Tadalafil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yuyu Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 7 Aug 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, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil administered in healthy male volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dutasteride&Tadalafil | Active comparator | Drug: Dutasteride 0.5 mg, Drug: Tadalafil 5 mgDutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose |
| YY-201 | Experimental | Drug: YY-201YY-201 capsule, singe dose |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 19 to 45 years
- BMI score 19 kg/m2 to 28 kg/m2
- SBP < 140 mmHg and ≤ 90 mmHg or DBP < 90 mmHg and ≥ 50 mmHg
- Eligible according to the laboratory results of hematology, blood chemistry and urinalysis
- Voluntarily signed the informed consent form
Key exclusion criteria (17 listed)
- Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months
- History of hypersensitivity
- history of Cardiovascular disease
- History of degenerative Retina disease
- Lactose intolerance
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 |
|---|---|---|
| Dutasteride 0.5 mgsingle dose | Drug | Dutasteride&Tadalafil |
| Tadalafil 5 mgsingle dose | Drug | Dutasteride&Tadalafil |
| YY-201single dose | Drug | YY-201 |
Primary outcome
Cmax
Time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
"Peak Plasma Concentration" of Dutasteride, tadalafil
3 secondary outcomes
Tmax
Time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
t1/2β
Time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
AUCinf
Time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
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 24 Nov 2017.
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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.
Hyeong-Seok Lim, M.D.,Ph.D. principal investigator
Asan Medical Center
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 Dutasteride 0.5 mg, Tadalafil 5 mg and YY-201 in people with Benign Prostatic Hyperplasia, run by Yuyu Pharma, Inc. 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 5 inclusion and 17 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 24 Nov 2017. 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?
Cmax (time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)). 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 24 Nov 2017.