HealthyPhase 1NCT01986673
Single-Dose Relative Bioavailability Study of SST-6006, a Topical Sildenafil Cream Versus Oral Sildenafil in Healthy Male Adults
A Phase 1 study testing 5% Sildenafil Cream (SST-6006) and Oral Sildenafil 50 mg in people with Healthy, run by Strategic Science & Technologies, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how a single dose of sildenafil cream (SST-6006) is absorbed and eliminated by the body, with and without the use of a condom, compared to a single oral sildenafil dose and to evaluate the safety of sildenafil cream. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 5% Sildenafil Cream (SST-6006) and Oral Sildenafil 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2013
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to sign and date the written informed consent form (ICF) before any study-specific screening procedures are performed
- Men between the ages of 18 to 55 years, inclusive
- Body mass index (BMI = weight [kg]/height [m]2) between 18.0 to 30.0 kg/m2, inclusive and body weight of at least 50 kg
- Nonsmoker or past smoker who has been abstinent for 6 months before study Day 1
- Have a high probability for compliance with and completion of the study, in the opinion of the Principal Investigator
- Healthy as determined by the investigator based on medical history, physical examination, clinical laboratory tests, vital sign measurements, and a normal 12-lead ECG
- Resting supine systolic blood pressure between 90 and 140 mmHg and resting supine diastolic blood pressure between 50 and 90 mmHg
- Must be able to achieve a successful erection
Who cannot join
- Presence or history of any disorder that may prevent the successful completion of the study
- Presence of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, genitourinary, or psychiatric disease, or other unstable medical condition
- Subjects with a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to study Day 1, or a history of coronary disease causing angina
- Subjects with retinitis pigmentosa and subjects with sickle cell anemia or related anemias, even if they feel clinically well at the time of screening. Subjects with retinitis pigmentosa will be identified by specifically asking whether they have the condition, if there are visual signs and symptoms of the condition (including questioning subjects as to whether they have difficulty seeing at night or in low light, and if they have any visual field deficits that indicate a loss of peripheral or central vision), or if there is a family history
- Subjects with anatomical deformations of the penis such as angulation, cavernosal fibrosis or Peyronie's disease
- History of orthostatic hypotension or orthostatic hypotension present at the screening visit, defined as a drop in systolic blood pressure greater than 20 mm Hg and a drop in diastolic blood pressure greater than 10 mm Hg with a change in position from supine to standing
Show all 19Show fewer
- A history of erectile dysfunction or a prostatectomy
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study Day 1
- History of drug abuse within 1 year before study Day 1
- History of alcoholism within 1 year before study Day 1, admitted alcohol abuse, or average consumption of more than 2 standard units of alcohol per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine)
- Use of any prescription drugs within 28 days before study Day 1, or over-the-counter drugs, including herbal supplements (except for the occasional use of acetaminophen [Tylenol] and vitamins) within 14 days before study Day 1. If the subject takes any prescription or OTC drugs at the direction of a health care provider, that provider should be consulted before medications are stopped for the purposes of study participation.
- Positive serologic findings for human immunodeficiency virus antibodies (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV)
- Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates) or alcohol screen
- Participation in a clinical trial within 30 days before study Day 1
- Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study Day 1
- Consumption of grapefruit or grapefruit-containing products within 72 hours before study Day 1
- Any skin breaks, irritation, or lesions present in the area to which the cream will be applied, assessed at screening and check-in
- A drug or food allergy which in the opinion of the Investigator contraindicates participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate how a single dose of sildenafil cream (SST-6006) is absorbed and eliminated by the body, with and without the use of a condom, compared to a single oral sildenafil dose and to evaluate the safety of sildenafil cream.
- Conditions
- Healthy
- Being tested
- 5% Sildenafil Cream (SST-6006), Oral Sildenafil 50 mg
- Keywords
- Pharmacokinetic Characterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Sildenafil Cream (SST-6006)Drug
5 % Sildenafil Cream
Oral Sildenafil 50 mgDrug
Oral Sildenafil 50 mg
| Study group | Role | What they receive |
|---|---|---|
| 5% Sildenafil Cream (SST-6006) | Experimental | 5% Sildenafil Cream Receives: Drug: 5% Sildenafil Cream (SST-6006) |
| Oral Sildenafil 50 mg | Active comparator | Oral Sildenafil 50 mg Receives: Drug: Oral Sildenafil 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, Tmax, AUC 0-tlast, AUC 0-t, Kel, AUC0-inf, t1/2, CL/F
Measured: 32 hours
Secondary outcomes (3)
Adverse Events
Number of subjects experiencing TEAEs.
Measured: 7 to 10 days
Clinical Chemistry Tests
Changes from baseline in clinical chemistry values
Measured: 1 day
Vital Signs
Vital sign changes from pre-dose
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Strategic Science & Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986673
- Sponsor's protocol ID
- SST-6006-001-01
- Status last verified
- Jan 2014
- First submitted
- 29 Oct 2013
- Last updated
- 27 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Relative Bioavailability Study of SST-6006, a Topical Sildenafil Cream Versus Oral Sildenafil in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT01986673
- Acronym / sponsor ID
- SST-6006-001-01
- Conditions
- Healthy
- Keywords
- Pharmacokinetic Characterization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Strategic Science & Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Nov 2013 (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 evaluate how a single dose of sildenafil cream (SST-6006) is absorbed and eliminated by the body, with and without the use of a condom, compared to a single oral sildenafil dose and to evaluate the safety of sildenafil cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% Sildenafil Cream (SST-6006) | Experimental | Drug: 5% Sildenafil Cream (SST-6006)5% Sildenafil Cream |
| Oral Sildenafil 50 mg | Active comparator | Drug: Oral Sildenafil 50 mgOral Sildenafil 50 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Willing and able to sign and date the written informed consent form (ICF) before any study-specific screening procedures are performed
- Men between the ages of 18 to 55 years, inclusive
- Body mass index (BMI = weight [kg]/height [m]2) between 18.0 to 30.0 kg/m2, inclusive and body weight of at least 50 kg
- Nonsmoker or past smoker who has been abstinent for 6 months before study Day 1
- Have a high probability for compliance with and completion of the study, in the opinion of the Principal Investigator
Key exclusion criteria (19 listed)
- Presence or history of any disorder that may prevent the successful completion of the study
- Presence of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, genitourinary, or psychiatric disease, or other unstable medical condition
- Subjects with a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to study Day 1, or a history of coronary disease causing angina
- Subjects with retinitis pigmentosa and subjects with sickle cell anemia or related anemias, even if they feel clinically well at the time of screening. Subjects with retinitis pigmentosa will be identified by specifically asking whether they have the condition, if there are visual signs and symptoms of the condition (including questioning subjects as to whether they have difficulty seeing at night or in low light, and if they have any visual field deficits that indicate a loss of peripheral or central vision), or if there is a family history
- Subjects with anatomical deformations of the penis such as angulation, cavernosal fibrosis or Peyronie's disease
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 |
|---|---|---|
| 5% Sildenafil Cream (SST-6006)5 % Sildenafil Cream | Drug | 5% Sildenafil Cream (SST-6006) |
| Oral Sildenafil 50 mgOral Sildenafil 50 mg | Drug | Oral Sildenafil 50 mg |
Primary outcome
Cmax, Tmax, AUC 0-tlast, AUC 0-t, Kel, AUC0-inf, t1/2, CL/F
Time frame: 32 hours
3 secondary outcomes
Adverse Events
Time frame: 7 to 10 days
Clinical Chemistry Tests
Time frame: 1 day
Vital Signs
Time frame: 1 day
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 27 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 5% Sildenafil Cream (SST-6006) and Oral Sildenafil 50 mg in people with Healthy, run by Strategic Science & Technologies, LLC at 1 site in United States.
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 8 inclusion and 19 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 27 Jan 2014. 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 United States. 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, Tmax, AUC 0-tlast, AUC 0-t, Kel, AUC0-inf, t1/2, CL/F (time frame: 32 hours). 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 27 Jan 2014.