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

NCT ID: NCT01986660

Last Updated: 2014-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Ibuprofen Cream (SST-0225)

Group Type: EXPERIMENTAL

Ibuprofen Cream (SST-0225)

Intervention Type: DRUG

Interventions

Ibuprofen Cream (SST-0225)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Strategic Science & Technologies, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SST Investigational Site

New York, New York, United States

Countries

United States

Other Identifiers

SST0225-US-011-001

Identifier Type: -

Identifier Source: org_study_id