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

NCT01887535 | Completed Phase 1

• 2 other identifiers: CR1016202013-000217-21
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 of Alzheimer's disease.

Conditions

Healthy

Keywords

Healthy; Elderly; Safety; Tolerability; Pharmacokinetic; Alzheimer's Disease; JNJ-54861911

Outcome Measures

Primary Outcomes (1)

• The number of volunteers who experience adverse events as a measure of safety and tolerability of JNJ-54861911 after multiple dose administration in the target dose range and above

  Up to 72 hours

Secondary Outcomes (6)

• Maximal tolerated dose (MTD) or maximal feasible exposure level of JNJ-54861911 after multiple dose administration

  Up to 72 hours

• Maximum observed plasma/cerebrospinal fluid (CSF) concentration (Cmax) of JNJ-54861911

  Up to 72 hours

• Levels of amyloid beta (Aβ) fragments (Aβ1-37, Aβ1-38, Aβ1-40 and Aβ1-42) in CSF after multiple dose administration

  Up to 36 hours

• Time to reach maximum observed plasma/CSF concentration of JNJ-54861911

  Up to 72 hours

• Area under the plasma/CSF concentration-time curve (AUC) from time 0 to t hours of JNJ-54861911

  Up to 72 hours

Study Arms (6)

Cohort 1: JNJ-54861911 3 mg

EXPERIMENTAL

Participants will be administered single doses of JNJ-54861911 on Days 1 to 14. Initially the doses will be once per day, but the frequency of daily dosing (eg, once-daily, twice-daily, three times daily) may change prior to or during study conduct depending on the pharmacokinetic data from the ongoing single-ascending dose study (54861911ALZ1001) or ongoing cohorts in this current study. Actual dose levels as well as the magnitude of dose escalation will depend on the results of the ongoing single-ascending dose study, the observed safety and tolerability profile as well as the observed exposures.

Drug: JNJ-54861911 3 mg

Cohort 2: JNJ-54861911 10 mg

EXPERIMENTAL

Drug: JNJ-54861911 10 mg

Cohort 3: JNJ-54861911 30 mg

EXPERIMENTAL

Drug: JNJ-54861911 30 mg

Cohort 4: JNJ-54861911 80 mg

EXPERIMENTAL

Drug: JNJ-54861911 80 mg

Cohort 5: JNJ-54861911 25 mg

EXPERIMENTAL

Drug: JNJ-54861911 25 mg

Cohorts 1-4: Placebo

PLACEBO COMPARATOR

Participants in Cohorts 1-4 will receive matching placebo.

Drug: Placebo

Interventions

JNJ-54861911 3 mg DRUG

JNJ-54861911 3 mg will be administered as an oral suspension formulation.

Cohort 1: JNJ-54861911 3 mg

JNJ-54861911 10 mg DRUG

JNJ-54861911 10 mg will be administered as an oral suspension formulation.

Cohort 2: JNJ-54861911 10 mg

JNJ-54861911 30 mg DRUG

JNJ-54861911 30 mg will be administered as an oral suspension formulation.

Cohort 3: JNJ-54861911 30 mg

JNJ-54861911 80 mg DRUG

JNJ-54861911 80 mg will be administered as an oral suspension formulation.

Cohort 4: JNJ-54861911 80 mg

JNJ-54861911 25 mg DRUG

JNJ-54861911 25 mg will be administered as a solid dose formulation.

Cohort 5: JNJ-54861911 25 mg

Placebo DRUG

Matching placebo will be administered as an oral suspension formulation.

Cohorts 1-4: Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

atabecestat

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 27, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

BE (1)