HealthyPhase 1NCT01986660
Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
A Phase 1 study testing Ibuprofen Cream (SST-0225) 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 Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibuprofen Cream (SST-0225)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed consent form
- Men, women, 18 to 55 years
- Females must not be pregnant or plan to become pregnant
- BMI 18 to 30 kg/m2
- Past or non-smoker
- High probability of compliance with completion of study
- Healthy as determined by investigator based on medical history, physical exam, clinical laboratory tests, vital sign measurements, ECGs
Who cannot join
- Presence or history of disorder that could interfere with completion of study
- Unstable medical condition
- Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug
- Positive Hep B, Hep C and/or HIV test
- Positive urine drug screen
- Any history of skin disorders, including psoriasis, eczema, tattoos, significant scarring, healing wounds, skin lesions on knees or elbows
Show all 15Show fewer
- Significant disease
- Any clinically important deviation from normal limits in physical exam, vital sign measurements, 12 lead ECG, clinical laboratory test
- History of drug abuse with 1 year
- History of alcoholism with 1 year
- Use of prescription medications or ibuprofen within 30 days of Day 1, use of OTC drugs, herbal supplements and vitamins within 14 days of Day 1.
- Use of investigational drug within 30 day of Day 1
- Acute disease state within 7 days of Day 1
- Consumption of grapefruit or grapefruit containing products within 72 hours of Day 1
- Tobacco use/caffeine use within 48 hours of Day 1
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions.
- Conditions
- Healthy
- Being tested
- Ibuprofen Cream (SST-0225)
- Keywords
- Pharmacokinetic Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen Cream (SST-0225)Drug
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen Cream (SST-0225) | Experimental | Not described Receives: Drug: Ibuprofen Cream (SST-0225) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2
Measured: 9 days
Secondary outcomes (4)
Clinical laboratory change from baseline
Measured: 14 days
Modified Berger Bowman Skin Assessment
Measured: 14 days
Vital Signs
Measured: 14 days
Adverse Events
Measured: 14 days
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 completionOct 2013
- Study completionOct 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT01986660
- Sponsor's protocol ID
- SST0225-US-011-001
- 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
- Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
- ClinicalTrials.gov ID
- NCT01986660
- Acronym / sponsor ID
- SST0225-US-011-001
- Conditions
- Healthy
- Keywords
- Pharmacokinetic Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Strategic Science & Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 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 Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen Cream (SST-0225) | Experimental | Drug: Ibuprofen Cream (SST-0225) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed consent form
- Men, women, 18 to 55 years
- Females must not be pregnant or plan to become pregnant
- BMI 18 to 30 kg/m2
- Past or non-smoker
Key exclusion criteria (15 listed)
- Presence or history of disorder that could interfere with completion of study
- Unstable medical condition
- Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug
- Positive Hep B, Hep C and/or HIV test
- Positive urine drug screen
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 |
|---|---|---|
| Ibuprofen Cream (SST-0225) | Drug | Ibuprofen Cream (SST-0225) |
Primary outcome
Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2
Time frame: 9 days
4 secondary outcomes
Clinical laboratory change from baseline
Time frame: 14 days
Modified Berger Bowman Skin Assessment
Time frame: 14 days
Vital Signs
Time frame: 14 days
Adverse Events
Time frame: 14 days
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 Ibuprofen Cream (SST-0225) 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 7 inclusion and 15 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, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2 (time frame: 9 days). 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; AzTrials last refreshed its copy on 6 Nov 2026.