Status:
COMPLETED
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Volunteers Compared With Placebo
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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.
Detailed Description
This study is a first-in-human, double-blind (neither investigator nor participant knows which treatment the participant receives), randomized (participants are assigned different treatments based on ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01827982
Start Date
March 1 2013
End Date
July 1 2013
Last Update
November 10 2014
Active Locations (1)
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1
Antwerp, Belgium