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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Volunteers Compared With Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01827982
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JNJ-54861911 which is currently being developed for the treatment of Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-54861911 1mg Drug: JNJ-54861911 3 mg Drug: JNJ-54861911 9 mg Drug: JNJ-54861911 27 mg Drug: JNJ-54861911 81 mg Drug: JNJ-54861911 160 mg Drug: JNJ-54861911 tbd Drug: Placebo Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Single-Ascending Dose Study To Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Subjects
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1 - Cohort 1: JNJ-54861911 1 mg
Following each dose level the observed safety and tolerability profile will be evaluated. The dose will be escalated only if the observed safety and tolerability profile is acceptable.
Drug: JNJ-54861911 1mg
JNJ-54861911 1 mg will be administered as a single oral dose after an overnight fast of at least 10 hours.

Experimental: Part 1 - Cohort 2: JNJ-54861911 3 mg Drug: JNJ-54861911 3 mg
JNJ-54861911 3 mg will be administered as a single oral dose.

Experimental: Part 1 - Cohort 3: JNJ-54861911 9 mg Drug: JNJ-54861911 9 mg
JNJ-54861911 9 mg will be administered as a single oral dose.

Experimental: Part 2 - Cohort 4: JNJ-54861911 9 mg Drug: JNJ-54861911 9 mg
Study drug will be administered after an overnight fast of at least 10 hours and within 120 minutes after placement of the spinal catheter.

Experimental: Part 2 - Cohort 5: JNJ-54861911 27 mg Drug: JNJ-54861911 27 mg
JNJ-54861911 27 mg will be administered as a single oral dose.

Experimental: Part 2 - Cohort 6: JNJ-54861911 81 mg Drug: JNJ-54861911 81 mg
JNJ-54861911 81 mg will be administered as a single oral dose.

Experimental: Part 2 - Cohort 7: JNJ-54861911 160 mg Drug: JNJ-54861911 160 mg
JNJ-54861911 160 mg will be administered as a single oral dose.

Experimental: Part 3 - Cohort 8: JNJ-54861911 (dose to be determined [tbd]) Drug: JNJ-54861911 tbd
The dose of JNJ-54861911 will be derived from the results obtained in Parts 1 and 2.

Placebo Comparator: Parts 1 through 3 - Placebo
Participants in each cohort will receive matching placebo.
Drug: Placebo
Matching placebo will be given as a single oral dose.




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of JNJ-54861911 [ Time Frame: Up to 96 hours ]
    The maximal tolerated dose (MTD) after single dose administration of JNJ-54861911 or the safety and tolerability at the maximum feasible dose level, whichever is reached first


Secondary Outcome Measures :
  1. Maximum observed plasma/cerebrospinal fluid (CSF) concentration (Cmax) of JNJ-54861911 [ Time Frame: Up to 96 hours post-dose ]
    Cmax is observed maximum plasma concentration of study drug, taken directly from the plasma concentration-time profile

  2. Time to reach maximum observed plasma/CSF concentration of JNJ-54861911 [ Time Frame: Up to 96 hours post-dose ]
    Time when Cmax is observed, taken directly from the plasma concentration-time profile

  3. Area under the plasma/CSF concentration-time curve (AUC) from time 0 to t hours of JNJ-54861911 [ Time Frame: Up to 96 hours post-dose ]
    The AUC (0 to t hours) is area under the plasma concentration-time curve from time 0 to t hours after dosing; t is time of the quantifiable concentration Clast

  4. Half-life of JNJ-54861911 [ Time Frame: Up to 96 hours post-dose ]
    Defined as 0.693/elimination rate constant

  5. Amyloid Beta profile in cerebrospinal fluid (CSF) [ Time Frame: Up to 36 hours post-dose ]
  6. Elimination rate constant [ Time Frame: Up to 96 hours post-dose ]
    Elimination rate constant is determined by linear regression of the terminal points of the ln-linear plasma/CSF concentration-time curve

  7. Area under the plasma/CSF concentration-time curve from time 0 to infinity of JNJ-54861911 [ Time Frame: Up to 96 hours post-dose ]
    The AUC (0 to infinity) is area under the plasma concentration-time curve from time 0 to t hours extrapolated to infinity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health
  • Must adhere to required contraception during and for 3 months after study

Specific Inclusion Criteria for Part 1:

  • Body mass index between 18 and 30 kg/m2
  • Male volunteers, between 18 and 54 years of age, inclusive

Specific Inclusion Criteria for Part 2:

  • Body mass index between 18 and 32 kg/m2
  • Women must be postmenopausal, permanently sterilized or otherwise be incapable of pregnancy
  • Healthy male or female volunteers, between 55 and 75 years of age, inclusive

Specific Inclusion Criteria for Part 3:

  • Male volunteers
  • If participated in Parts 1 or 2, specific inclusion criteria for Part 1 (young) or Part 2 (elderly) may apply

Exclusion Criteria:

  • Clinically significant medical or psychiatric illness
  • Alcohol or substance abuse; excessive nicotine or caffeine use
  • Recently received an investigational drug, vaccine, or invasive medical device
  • Unable to abide by protocol restrictions on use of other medications
  • History or family history of spontaneous, prolonged or severe bleeding of unclear origin or of blood clotting
  • Current anemia

Specific Exclusion Criteria for Part 2:

  • History of lower back pain or scoliosis and/or major (lumbar) back surgery
  • Allergic to local anesthetics and/or iodine
  • Increased intracranial pressure based on fundoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827982


Locations
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Belgium
Antwerpen, Belgium
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01827982     History of Changes
Other Study ID Numbers: CR101083
2013-000215-24 ( EudraCT Number )
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014

Keywords provided by Janssen Research & Development, LLC:
Healthy
Safety
Tolerability
Pharmacokinetic
Alzheimer's Disease
JNJ-54861911