NCT02023255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

December 23, 2013

Last Update Submit

January 23, 2014

Conditions

Healthy

Keywords

HealthyJNJ-39393406SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (15)

  • Number of participants with adverse events

    Up to Day 56

  • Maximum Observed Plasma Concentration (Cmax) of JNJ-39393406 in Part A of the study

    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2 to 6 (predose), Day 8 (24 hours), and Days 9, 10 (48/72 hours)

  • Maximum Observed Plasma Concentration (Cmax) of JNJ-39393406 in Part B of the study

    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 (predose), Day 12 (predose, 1, 2, 4, 6, 8 hours), Day 14 (24 hours), and Days 15, 16 (48/72 hours)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-39393406 in Part A of the study

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2 to 6 (predose), Day 8 (24 hours), and Days 9, 10 (48/72 hours)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-39393406 in Part B of the study

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 (predose), Day 12 (predose, 1, 2, 4, 6, 8 hours), Day 14 (24 hours), and Days 15, 16 (48/72 hours)

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[t]) of JNJ-39393406 in Part A of the study

    The Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC\[t\]) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2 to 6 (predose), Day 8 (24 hours), and Days 9, 10 (48/72 hours)

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[t]) of JNJ-39393406 in Part B of the study

    The Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC\[t\]) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 (predose), Day 12 (predose, 1, 2, 4, 6, 8 hours), Day 14 (24 hours), and Days 15, 16 (48/72 hours)

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[infinity]) of JNJ-39393406 in Part A of the study

    The AUC(infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2 to 6 (predose), Day 8 (24 hours), and Days 9, 10 (48/72 hours)

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[infinity]) of JNJ-39393406 in Part B of the study

    The AUC(infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 (predose), Day 12 (predose, 1, 2, 4, 6, 8 hours), Day 14 (24 hours), and Days 15, 16 (48/72 hours)

  • Terminal Rate Constant (Lambda[z]) of JNJ-39393406 in Part A of the study

    Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2 to 6 (predose), Day 8 (24 hours), and Days 9, 10 (48/72 hours)

  • Terminal Rate Constant (Lambda[z]) of JNJ-39393406 in Part B of the study

    Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 (predose), Day 12 (predose, 1, 2, 4, 6, 8 hours), Day 14 (24 hours), and Days 15, 16 (48/72 hours)

  • Plasma Decay Half-Life (t1/2) of JNJ-39393406 in Part A of the study

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2 to 6 (predose), Day 8 (24 hours), and Days 9, 10 (48/72 hours)

  • Plasma Decay Half-Life (t1/2) of JNJ-39393406 in Part B of the study

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Days 1 and 7 (predose, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 hours), Days 2, 3, 4, 5, 6, 8, 9, 10, 11, 13 (predose), Day 12 (predose, 1, 2, 4, 6, 8 hours), Day 14 (24 hours), and Days 15, 16 (48/72 hours)

  • Change from baseline in cognition in elderly and young healthy participants in Part A of the study

    For cognitive testing a computerized test battery will be applied, focusing on memory, executive function and attention.

    Baseline to Day 6

  • Change from baseline in cognition in elderly and young healthy participants in Part B of the study

    For cognitive testing a computerized test battery will be applied, focusing on memory, executive function and attention.

    Baseline to Day 13

Study Arms (8)

Part A: Cohort 1

EXPERIMENTAL

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.

Drug: JNJ-39393406Other: Placebo

Part A: Cohort 2

EXPERIMENTAL

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.

Drug: JNJ-39393406Other: Placebo

Part A: Cohort 3

EXPERIMENTAL

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.

Drug: JNJ-39393406Other: Placebo

Part A: Cohort 4

EXPERIMENTAL

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.

Drug: JNJ-39393406Other: Placebo

Part A: Cohort 5

EXPERIMENTAL

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.

Drug: JNJ-39393406Other: Placebo

Part B: Cohort A

EXPERIMENTAL

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.

Drug: JNJ-39393406Other: Placebo

Part B: Cohort B

EXPERIMENTAL

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.

Drug: JNJ-39393406Other: Placebo

Part B: Cohort C

EXPERIMENTAL

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.

Drug: JNJ-39393406Other: Placebo

Interventions

JNJ-39393406DRUG

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.

Part A: Cohort 1Part A: Cohort 2Part A: Cohort 3Part A: Cohort 4Part A: Cohort 5Part B: Cohort APart B: Cohort BPart B: Cohort C
PlaceboOTHER

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 1Part A: Cohort 2Part A: Cohort 3Part A: Cohort 4Part A: Cohort 5Part B: Cohort APart B: Cohort BPart B: Cohort C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Interventions

JNJ-39393406

Study Officials

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

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 30, 2013

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

BE(1)