Status:
COMPLETED
A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate skin irritation and photo irritation of JNJ 10229570-AAA on intact skin of Japanese healthy male participants.
Detailed Description
This is a single center, interpreter-blinded (the person interpreting the results does not know the name of the assigned drug), randomized (drug is assigned by chance like flipping a coin), vehicle-co...
Eligibility Criteria
Inclusion
- Signed an informed consent document
- Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic
- Electrocardiogram (ECG) consistent with normal cardiac conduction and function
- Non-smoker
- Agree to use an adequate contraception method
Exclusion
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, biochemistry or urinalysis
- Clinically significant abnormal physical examination, vital signs or ECG
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the study treatment
- History of drug or alcohol abuse within the past 5 years
- Drug allergy or drug hypersensitivity
- Blood donation, depending on the volume of blood collection
- Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
- Dermatological disease at application site
- Photosensitivity
- Exposure to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to study treatment or planned during the study period
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01494714
Start Date
August 1 2011
End Date
September 1 2011
Last Update
October 31 2012
Active Locations (2)
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1
Fukukoka, Japan
2
Hakata, Japan