Status:

COMPLETED

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54861911 in Healthy Elderly Participants

Lead Sponsor:

Janssen Research & Development, LLC

Conditions:

Healthy

Eligibility:

All Genders

55-75 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-ascending dose JNJ-54861911 which is currently being developed for the treatment o...

Detailed Description

This multiple ascending dose study is anticipated to enroll 5 cohorts (small groups). Cohorts 1 to 4 will be conducted as a double-blind (neither investigator nor participant knows which treatment the...

Eligibility Criteria

Inclusion

  • Good general health
  • Body mass index (BMI) between 18 and 32 kg/m2, inclusive
  • Women must be postmenopausal, permanently sterilized or otherwise be incapable of pregnancy
  • Must adhere to required contraception during and for 3 months after study

Exclusion

  • 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
  • Relevant history of lower back pain or scoliosis and/or major (lumbar) back surgery
  • Allergic to local anesthetics and/or iodine

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT01887535

Start Date

May 1 2013

End Date

December 1 2013

Last Update

January 14 2014

Active Locations (1)

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Antwerp, Belgium

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54861911 in Healthy Elderly Participants | DecenTrialz