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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1
Antwerp, Belgium