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

NCT01827982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-11-10

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

DRUG

JNJ-54861911 3 mg

JNJ-54861911 3 mg will be administered as a single oral dose.

DRUG

JNJ-54861911 9 mg

JNJ-54861911 9 mg will be administered as a single oral dose.

DRUG

JNJ-54861911 27 mg

JNJ-54861911 27 mg will be administered as a single oral dose.

DRUG

JNJ-54861911 81 mg

JNJ-54861911 81 mg will be administered as a single oral dose.

DRUG

JNJ-54861911 160 mg

JNJ-54861911 160 mg will be administered as a single oral dose.

DRUG

JNJ-54861911 tbd

The dose of JNJ-54861911 will be derived from the results obtained in Parts 1 and 2.

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.

DRUG

Placebo

Matching placebo will be given as a single oral dose.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01827982 on ClinicalTrials.gov