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

NCT ID: NCT01492647

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

Detailed 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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ 10229570-AAA 1.2%

Group Type: EXPERIMENTAL

JNJ 10229570-AAA 1.2%

Intervention Type: DRUG

One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.

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

Intervention Type: DRUG

One single application of 2.5 mL of the color-matched vehicle will be applied to the face, neck, shoulders, chest and to the upper back areas.

JNJ 10229570-AAA 3.6%

Group Type: EXPERIMENTAL

JNJ 10229570-AAA 3.6%

Intervention Type: DRUG

One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.

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

Intervention Type: DRUG

One single application of 2.5 mL of the color-matched vehicle will be applied to the face, neck, shoulders, chest and to the upper back areas.

Interventions

JNJ 10229570-AAA 1.2%

One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.

Intervention Type: DRUG

JNJ 10229570-AAA 3.6%

One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.

Intervention Type: DRUG

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

One single application of 2.5 mL of the color-matched vehicle will be applied to the face, neck, shoulders, chest and to the upper back areas.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Fukukoka, , Japan

Hakata, , Japan

Countries

Japan

Other Identifiers

10229570-JPN-02

Identifier Type: OTHER

Identifier Source: secondary_id

CR018673

Identifier Type: -

Identifier Source: org_study_id