Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
1 other identifier
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 29, 2013
CompletedFirst Posted
Study publicly available on registry
November 18, 2013
CompletedJanuary 27, 2014
January 1, 2014
Same day
October 29, 2013
January 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2
9 days
Secondary Outcomes (4)
Clinical laboratory change from baseline
14 days
Modified Berger Bowman Skin Assessment
14 days
Vital Signs
14 days
Adverse Events
14 days
Study Arms (1)
Ibuprofen Cream (SST-0225)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SST Investigational Site
New York, New York, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 18, 2013
Study Start
October 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
January 27, 2014
Record last verified: 2014-01