Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ibuprofen Cream (SST-0225)

• Registration Number: NCT01986660
• Lead Sponsor: Strategic Science & Technologies, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ibuprofen Cream (SST-0225)	Ibuprofen Cream (SST-0225)	-

Primary Outcome Measures

Name	Time	Method
Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2	9 days

Secondary Outcome Measures

Name	Time	Method
Clinical laboratory change from baseline	14 days
Vital Signs	14 days
Modified Berger Bowman Skin Assessment	14 days
Adverse Events	14 days

Trial Locations

Locations (1)

SST Investigational Site; 🇺🇸 New York, New York, United States