A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39393406 in Healthy Participants

NCT ID: NCT02023255

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple dose administration of JNJ-39393406 in young healthy participants, and subsequently in healthy elderly participants.

Detailed Description

This is a double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (study in which an inactive substance is given to one group of participants, while the study medication is given to another group), randomized (the study medication is assigned by chance), and multiple ascending dose (participants will receive multiple doses of study medication and the dose level is subsequently escalated in further groups) study. This study will consist of screening phase (between 21 and 2 days prior to dose administration), a double-blind treatment phase (Part A - 7 days and Part B - 13 days), and a follow-up phase (within 7 to 14 days after last dose administration). In Part A of the multiple ascending dose study approximately 40 young healthy male participants will be randomly allocated to 5 cohorts (group of individuals with similar characteristics) to receive single daily doses of either JNJ-39393406 or placebo for 7 consecutive days. After each dose level, safety, tolerability, and pharmacokinetic (PK) profile (explores what the body does to a medication) of the dose level will be evaluated and the next dose level will be escalated considering the safety and tolerability data. In Part B of the study approximately 48 elderly healthy male and female participants will be randomly allocated to A, B, and C cohorts to receive single daily doses of either JNJ-39393406 or placebo for 13 consecutive days. Dose levels in Part B will be selected based on the PK data from Part A. In both Part A and Part B of the study the dose levels will be increased only after acceptable safety and tolerability data will be obtained. Safety evaluations will include assessments of adverse events, clinical laboratory tests, 24-hour creatinine clearance, Holter monitoring, telemetry, electrocardiogram, vital signs, physical examination, and neurological examination. The study duration for each participant will be approximately 8 weeks.

Conditions

Healthy

Study Design

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

Study Groups

Part A: Cohort 1

8 participants will be included in this cohort. 6 participants will receive a single dose of 50 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days.

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Placebo

Intervention Type: OTHER

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Part A: Cohort 2

8 participants will be included in this cohort. 6 participants will receive a single dose of 150 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days.

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Placebo

Intervention Type: OTHER

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Part A: Cohort 3

8 participants will be included in this cohort. 6 participants will receive a single dose of 450 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days.

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Placebo

Intervention Type: OTHER

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Part A: Cohort 4

8 participants will be included in this cohort. 6 participants will receive a single dose of 1,350 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days.

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Placebo

Intervention Type: OTHER

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Part A: Cohort 5

8 participants will be included in this cohort. 6 participants will receive a single dose of 2,700 mg JNJ-39393406 and 2 participants will receive placebo for 7 consecutive days.

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Placebo

Intervention Type: OTHER

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Part B: Cohort A

16 participants will be included in this cohort. 12 participants will receive a single dose of JNJ-39393406 selected based on the pharmacokinetic (PK) data from Part A of the study and 4 participants will receive placebo for 13 consecutive days.

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Placebo

Intervention Type: OTHER

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Part B: Cohort B

16 participants will be included in this cohort. 12 participants will receive a single dose of JNJ-39393406 selected based on the PK data from Part A of the study and 4 participants will receive placebo for 13 consecutive days.

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Placebo

Intervention Type: OTHER

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Part B: Cohort C

16 participants will be included in this cohort. 12 participants will receive a single dose of JNJ-39393406 selected based on the PK data from Part A of the study and 4 participants will receive placebo for 13 consecutive days.

Group Type: EXPERIMENTAL

JNJ-39393406

Intervention Type: DRUG

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Placebo

Intervention Type: OTHER

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Interventions

JNJ-39393406

In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.

Intervention Type: DRUG

Placebo

In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Willing to adhere to the prohibitions and restrictions specified in the protocol
• Part A: Body mass index (BMI) between 18 and 30 kg/m2, inclusive (BMI = weight/height2)
• Part B: Female participants must be postmenopausal (for at least 12 months)
• BMI between 18 and 33 kg/m2, inclusive

Exclusion Criteria

• Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
• Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable
• Clinically significant abnormal 24 hour Holter monitoring at screening in the opinion of the investigator
• Significant history of or current psychiatric or neurological illness
• Serology positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

39393406EDI1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR015760

Identifier Type: -

Identifier Source: org_study_id