Benign Prostate HyperplasiaPhase 1NCT02839122
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
A Phase 1 study testing Tadalafil and Dutasteride in people with Benign Prostate Hyperplasia, run by Yuyu Pharma, Inc..
Trial summary
This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of Dutasteride and Tadalafil 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 Prostate Hyperplasia
- What is being tested?
- Tadalafil and Dutasteride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 23 Sep 2016
- 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
- History of vision loss
Show all 16Show 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
- Excessive alcohol consumption (> 3 units/week, 1 unit)
- Taking food which may affect Clinical trial within 7 days
- Positive result from Urinary test, Serum test
- Not eligible due to other reasons including laboratory results
- Clinically significant disorders result from Electrocardiography test
- Not eligible due to investigator's judgments
About this study
This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy male volunteers.
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- Tadalafil, Dutasteride
- 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.
TadalafilDrug
DutasterideDrug
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride, Tadalafil | Experimental | Not described Receives: Drug: Tadalafil; Drug: Dutasteride |
| Tadalafil, Dutasteride | Experimental | Not described Receives: Drug: Tadalafil; Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve(AUC) of Dutasteride
Measured: 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,32,48,72,96,144,192,240 hours
Area Under the Curve(AUC) of Tadalafil, Dutasteride
Measured: 0,24,72,96,96.5,97,97.5,98,99,100,102,104,106,108,120,120.5,121,121.5,122,122.5,123,123.5,124,125,126,128,132,144,152,168,192,216,264,312,360 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completion23 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuyu Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- hyeng-seok H Lim, ph.D, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839122
- Sponsor's protocol ID
- YY_DUTA_2016
- Status last verified
- Apr 2017
- First submitted
- 13 Jun 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02839122
- Acronym / sponsor ID
- YY_DUTA_2016
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- Dutasteride, Tadalafil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yuyu Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 20 Jul 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.
This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy male volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dutasteride, Tadalafil | Experimental | Drug: Tadalafil, Drug: Dutasteride |
| Tadalafil, Dutasteride | Experimental | Drug: Tadalafil, Drug: Dutasteride |
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 (16 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 |
|---|---|---|
| Tadalafil | Drug | Dutasteride, Tadalafil, Tadalafil, Dutasteride |
| Dutasteride | Drug | Dutasteride, Tadalafil, Tadalafil, Dutasteride |
Primary outcome
Area Under the Curve(AUC) of Dutasteride
Time frame: 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,32,48,72,96,144,192,240 hours
Area Under the Curve(AUC) of Tadalafil, Dutasteride
Time frame: 0,24,72,96,96.5,97,97.5,98,99,100,102,104,106,108,120,120.5,121,121.5,122,122.5,123,123.5,124,125,126,128,132,144,152,168,192,216,264,312,360 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 4 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
hyeng-seok H Lim, ph.D principal investigator
AIDS Malignancy Consortium
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tadalafil and Dutasteride in people with Benign Prostate Hyperplasia, run by Yuyu Pharma, Inc..
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 16 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Area Under the Curve(AUC) of Dutasteride (time frame: 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,32,48,72,96,144,192,240 hours). 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?
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 4 Apr 2017.