A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Acne Vulgaris

Treatments

Drug: JNJ 10229570-AAA 1.2%

Drug: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA

Drug: JNJ 10229570-AAA 3.6%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01492647

10229570-JPN-02 (Other Identifier)

CR018673

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne.

Full description

This is a randomized (drug assigned by chance like flipping a coin), double blinded (neither physician nor patient knows the name of the assigned drug), single dose ascending study of JNJ 10229570-AAA in Japanese participants with acne. The study will evaluate the safety and pharmacokinetics ([PK] how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of M1 (active metabolite) in a total of eighteen (18) participants enrolled in the study, nine (9) in each group. Each participant will receive JNJ 10229570-AAA at 1.2%, 3.6% or vehicle in a cream formulation as a 2.5 mL application, to the face, neck, shoulders, chest and upper back areas. The investigational product will be washed off after the blood sampling at 24 hours after application. Safety and tolerability will be evaluated throughout the study and a topical dermatological assessment will be done by the dermatologists. The total duration of the study will be maximum 35 days.

Enrollment

18 patients

Sex

All

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have Acne vulgaris, presenting at least inflammatory lesion on the face
Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman)
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
Adequate contraception method for both men and women. If a woman, must have a negative pregnancy test
Signed an informed consent document

Exclusion criteria

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 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