Erectile DysfunctionPhase 1/2NCT03102398
A Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction Patients
A Phase 1/2 study testing TR-399 (5% Vardenafil HCl·3H2O, topical gel) in people with Erectile Dysfunction, run by Tritech Biopharmaceuticals Co., Ltd. at 1 site in Taiwan.
Trial summary
The purpose of this phase I/IIa study is to assess the safety and tolerability profile of TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted via a single-arm and open-label fashion. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- TR-399 (5% Vardenafil HCl·3H2O, topical gel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Mar 2017to 31 Mar 2018
- Phase
- Phase 1/2
- 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 20 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase I
- Male aged between 20~40 years old ;
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and electrocardiogram;
- Body mass index (BMI) between 18.5 and 27, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]);
- Clinically normal, including non-clinical significant abnormal, hematology, biochemistry and urinalysis determinations based on investigator's discretion;
- Subject is willing and able to comply with study procedures and has signed informed consent.
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- With Erectile Function domain of the IIEF score of 25~30
- Phase IIa
- Male aged between 20~70 years old ;
- Diagnosed and confirmed ED for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the National Institutes of Health (NIH) consensus report 1993;
- With Erectile Function domain of the IIEF score of 13~24;
- Stable relationship for more than 3 months;
- At least 4 sexual intercourse attempts at 4 different days during 4-week period prior the screening;
- With a testosterone level ≥ 240 ng/dL (either naturally or through androgen replacement therapy);
- Subject is willing and able to comply with study procedures and has signed informed consent.
Who cannot join
- Phase I
- Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of study product
- Subject who has a history or evidence of a medical condition that would expose him to an undue risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator
- Subject has received any investigational agent within 4 weeks prior to the screening visit
- Subject has taken or potentially takes any prescription medication and/or over-the-counter medication from 1 week prior to the screening visit to the end of treatment (Day 15)
- Sexual partner is a pregnant or lactating female or a female with childbearing potential not taking reliable contraceptive methods during study period Note: Acceptable contraceptive forms include
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- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- Use of PDE-5 inhibitors within the last 2 weeks prior to the screening visit
- Use of alpha blockers or nitrates within 2 weeks prior to the screening visit
- Subject who has prolongation of QT interval >500 ms (long QT syndrome)
- Any of the following hematologic abnormalities:
- Hemoglobin < 10.0 g/dL
- ANC < 1,500/μL,
- Platelets < 75,000 /μL
- Any of the following serum chemistry abnormalities:
- Total bilirubin > 1.5 × ULN,
- gamma-GT > 2.5 x ULN,
- Alk-P > 2.5 x ULN,
- Serum albumin < 3.0 g/dL, e Any other ≥ Grade 2 laboratory abnormality (based on CTCAE) at Screening visit (other than those listed above)
- With history of stroke, myocardial infarction, or Coronary Artery Bypass Graft (CABG) surgery within the last 6 months prior to the screening visit
- With history of cardiac failure (NYHA class 2 or above), unstable angina, or life-threatening arrhythmia within the last 6 months prior to the screening visit Note: NYHA = New York Heart Association
- With blood pressures as systolic blood pressure <90mmHg or > 170mmHg or diastolic blood pressure <50mmHg or > 120 mmHg
- History of orthostatic hypotension Note: Orthostatic hypotension is defined as a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg.
- History of syncope
- Hereditary degenerative retinal disorders
- History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
- Skin diseases, infection or cuts in penile area
- History of psychiatric disorder
- History of spinal cord injury
- Use of HIV protease inhibitors (strong cytochrome P450 CYP3A4 inhibitors), such as indinavir or ritonavir within 2 weeks prior to the screening visit
- History of left ventricular outflow obstruction, such as aortic stenosis and hypertrophic cardiomyopathy
- With any cardiovascular disorder that is not suitable for sexual activities.
- Use of antiarrhythmic agents class IA (such as quinidine, or procainamide) and class III (such as amiodarone or sotalol) within 2 weeks prior to the screening visit
- With priapism, such as sickle cell anemia, multiple myeloma or leukemia
- Phase IIa
- Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of study product
- Participated in another clinical trial and received any investigational drug within four weeks prior to the screening visit
- Impaired hepatic function defined as alanine aminotransferase/aspartate aminotransferase (ALT/AST) or alkaline phosphatase (ALP) at least 2.5 times upper referenced limit
- Impaired renal function defined as serum-creatinine at least 1.3 mg/dL (at least 115 mmol/L)
- With history of stroke, myocardial infarction, or Coronary Artery Bypass Graft (CABG) surgery within the last 6 months prior to the screening visit
- With history of cardiac failure (NYHA class 2 or above), unstable angina, or life-threatening arrhythmia within the last 6 months prior to the screening visit Note: NYHA = New York Heart Association
- With blood pressures as systolic blood pressure <90mmHg or > 170mmHg or diastolic blood pressure <50mmHg or > 120 mmHg
- With any uncontrolled illness or a history of any illness judged by the investigator that entering the trial may be detrimental to the patient
- Current treatment with systemic corticosteroids
- History of prostatectomy due to prostate cancer, including nerve-sparing techniques
- Use of alpha blockers or nitrates within 4 weeks prior to the screening visit
- Use of PDE-5 inhibitor, or other treatments for erectile dysfunction within the last 4 weeks prior to the screening visit
- Sexual partner is a pregnant or lactating female or a female with childbearing potential not taking reliable contraceptive methods during study period Note: Acceptable contraceptive forms include
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- ED due to structural abnormality of the penis
- With a history of HIV infection Note: HIV = Human Immunodeficiency Virus
- Subject who has prolongation of QT interval >500 ms (long QT syndrome)
- Any of the following hematologic abnormalities:
- Hemoglobin < 10.0 g/dL
- ANC < 1,500/μL,
- Platelets < 75,000 /μL
- Any of the following serum chemistry abnormalities:
- Total bilirubin > 1.5 × ULN,
- gamma-GT > 2.5 x ULN,
- Alk-P > 2.5 x ULN,
- Serum albumin < 3.0 g/dL, e Any other ≥ Grade 2 laboratory abnormality (based on CTCAE) at Screening visit (other than those listed above)
- History of orthostatic hypotension Note: Orthostatic hypotension is defined as a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg
- History of syncope
- Hereditary degenerative retinal disorders
- History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
- Skin diseases, infection or cuts in penile area
- History of psychiatric disorder
- History of spinal cord injury
- Use of HIV protease inhibitors (strong cytochrome P450 CYP3A4 inhibitors), such as indinavir or ritonavir, within 2 weeks prior to the screening visit
- History of left ventricular outflow obstruction, such as aortic stenosis and hypertrophic cardiomyopathy
- With any cardiovascular disorder that is not suitable for sexual activities.
- Use of antiarrhythmic agents class IA (such as quinidine, or procainamide) and class III (such as amiodarone or sotalol), within 2 weeks prior to the screening visit
- With priapism, such as sickle cell anemia, multiple myeloma or leukemia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memorial Hospital
Taipei, 10449
Wei-Kung Tsai, 886-2-2543-3535
About this study
Official title: An Open-Label Phase I/IIa Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction Patients
The purpose of this phase I/IIa study is to assess the safety and tolerability profile of TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted via a single-arm and open-label fashion.
Read the detailed description
Several oral medications containing PDE5 inhibitors, including sildenafil (Viagra®, Pfizer), vardenafil (Levitra®, Bayer) and tadalafil (Cialis®, Lilly), have been marketed for the treatment of ED. Many considerations should be taken before patients are prescribed with PDE5 inhibitor medications, which may cause systemic side effects and should not be taken with nitrates or alpha-blockers.
The active pharmaceutical ingredient (API) of TR399 is 5% Vardenafil HCl·3H2O. Non-clinical studies have shown that the topical use of TR399 can enhance erection and sexual behavior in animal models without causing irritancy and phototoxicity.
This study is designed as a single-arm and open-label fashion in order to explore the safety and PK of TR399 in healthy volunteers, as well as the safety, PK and efficacy of TR399 in patients with ED.
- Conditions
- Erectile Dysfunction
- Being tested
- TR-399 (5% Vardenafil HCl·3H2O, topical gel)
- Keywords
- Erectile Dysfunction, PDE5 inhibitor, Sexual Dysfunction
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-399 (5% Vardenafil HCl·3H2O, topical gel)Drug
5% Vardenafil HCl·3H2O, topical gel, 2 drops (50ul, 2.5mg), q.d.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm and Open-label Study | Experimental | Not described Receives: Drug: TR-399 (5% Vardenafil HCl·3H2O, topical gel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation of TR399 assessed by Incidence of AEs and SAEs
Phase I Incidence of AEs and SAEs
Measured: 24 days
Safety and efficacy evaluation of TR399 assessed by change from baseline to the last evaluation visit during the treatment period in score of IIEF-15 Erectile Function domain
Phase IIa Change from baseline to the last evaluation visit during the treatment period in score of IIEF-15 Erectile Function domain
Measured: 83 days
Secondary outcomes (11)
Safety evaluation of TR399 assessed by Maximum Plasma Concentration (Cmax)
PK profiles - Maximum Plasma Concentration (Cmax) will be measured for safety evaluation of TR399 of Phase I
Measured: 24 days
Safety evaluation of TR399 assessed by Area Under the Curve (AUC)
PK profiles - Area Under the Curve (AUC) will be measured for safety evaluation of TR399 of Phase I
Measured: 24 days
Safety evaluation of TR399 assessed by Time of maximum concentration (Tmax)
PK profiles - Time of maximum concentration (Tmax) will be measured for safety evaluation of TR399 of Phase I
Measured: 24 days
Change from baseline to post-treatment visits in score of IIEF-15 Erectile Function domain
Score of IIEF-15 Erectile Function will be assessed for efficacy evaluation of TR399 of Phase IIa
Measured: 83 days
Change from baseline to post-treatment visits in SEP Question 2
SEP Question 2 will be assessed for efficacy evaluation of TR399 of Phase IIa
Measured: 83 days
Change from baseline to post-treatment visits in SEP Question 3
SEP Question 3 will be assessed for efficacy evaluation of TR399 of Phase IIa
Measured: 83 days
Changes from baseline to post-treatment visits in vital signs, physical examination and laboratory examination results
Vital signs, physical examination and laboratory examination results will be assessed for safety evaluation of TR399 of Phase IIa
Measured: 83 days
Incidence of AEs and SAEs
Incidence of AEs and SAEs will be assessed for safety evaluation of TR399 of Phase IIa
Measured: 83 days
Safety evaluation of TR399 assessed by Maximum Plasma Concentration (Cmax) for the first 6 evaluable ED patients
PK profiles - Maximum Plasma Concentration (Cmax) will be measured for safety evaluation of TR399 of Phase IIa
Measured: 45 days
Safety evaluation of TR399 assessed by Area Under the Curve (AUC) for the first 6 evaluable ED patients
PK profiles - Area Under the Curve (AUC) will be measured for safety evaluation of TR399 of Phase IIa
Measured: 45 days
Safety evaluation of TR399 assessed by Time of maximum concentration (Tmax) for the first 6 evaluable ED patients
PK profiles - Time of maximum concentration (Tmax) will be measured for safety evaluation of TR399 of Phase IIa
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start31 Mar 2017
- Primary completion31 Jan 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tritech Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102398
- Sponsor's protocol ID
- TR399
- Status last verified
- Jun 2017
- First submitted
- 20 Mar 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I/IIa Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction Patients
- ClinicalTrials.gov ID
- NCT03102398
- Acronym / sponsor ID
- TR399
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, PDE5 inhibitor, Sexual Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Tritech Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 5 Apr 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.
The purpose of this phase I/IIa study is to assess the safety and tolerability profile of TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted via a single-arm and open-label fashion.
Detailed description
Several oral medications containing PDE5 inhibitors, including sildenafil (Viagra®, Pfizer), vardenafil (Levitra®, Bayer) and tadalafil (Cialis®, Lilly), have been marketed for the treatment of ED. Many considerations should be taken before patients are prescribed with PDE5 inhibitor medications, which may cause systemic side effects and should not be taken with nitrates or alpha-blockers.
The active pharmaceutical ingredient (API) of TR399 is 5% Vardenafil HCl·3H2O. Non-clinical studies have shown that the topical use of TR399 can enhance erection and sexual behavior in animal models without causing irritancy and phototoxicity.
This study is designed as a single-arm and open-label fashion in order to explore the safety and PK of TR399 in healthy volunteers, as well as the safety, PK and efficacy of TR399 in patients with ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm and Open-label Study | Experimental | Drug: TR-399 (5% Vardenafil HCl·3H2O, topical gel) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Phase I
- Phase IIa
Key exclusion criteria (77 listed)
- Phase I
- Phase IIa
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 |
|---|---|---|
| TR-399 (5% Vardenafil HCl·3H2O, topical gel)5% Vardenafil HCl·3H2O, topical gel, 2 drops (50ul, 2.5mg), q.d. | Drug | Single-arm and Open-label Study |
Primary outcome
Safety evaluation of TR399 assessed by Incidence of AEs and SAEs
Time frame: 24 days
Phase I Incidence of AEs and SAEs
Safety and efficacy evaluation of TR399 assessed by change from baseline to the last evaluation visit during the treatment period in score of IIEF-15 Erectile Function domain
Time frame: 83 days
Phase IIa Change from baseline to the last evaluation visit during the treatment period in score of IIEF-15 Erectile Function domain
11 secondary outcomes
Safety evaluation of TR399 assessed by Maximum Plasma Concentration (Cmax)
Time frame: 24 days
Safety evaluation of TR399 assessed by Area Under the Curve (AUC)
Time frame: 24 days
Safety evaluation of TR399 assessed by Time of maximum concentration (Tmax)
Time frame: 24 days
Change from baseline to post-treatment visits in score of IIEF-15 Erectile Function domain
Time frame: 83 days
Change from baseline to post-treatment visits in SEP Question 2
Time frame: 83 days
Change from baseline to post-treatment visits in SEP Question 3
Time frame: 83 days
Changes from baseline to post-treatment visits in vital signs, physical examination and laboratory examination results
Time frame: 83 days
Incidence of AEs and SAEs
Time frame: 83 days
Safety evaluation of TR399 assessed by Maximum Plasma Concentration (Cmax) for the first 6 evaluable ED patients
Time frame: 45 days
Safety evaluation of TR399 assessed by Area Under the Curve (AUC) for the first 6 evaluable ED patients
Time frame: 45 days
Safety evaluation of TR399 assessed by Time of maximum concentration (Tmax) for the first 6 evaluable ED patients
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TR-399 (5% Vardenafil HCl·3H2O, topical gel) in people with Erectile Dysfunction, run by Tritech Biopharmaceuticals Co., Ltd. at 1 site in Taiwan.
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 15 inclusion and 77 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: status not confirmed, as of the sponsor's last update on 22 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 Taiwan. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Chi Lai (886-2-2809-8274, camilla.lai@tritechbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation of TR399 assessed by Incidence of AEs and SAEs (time frame: 24 days). 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 22 Nov 2017.