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

NCT01827982 | Completed Phase 1

• 2 other identifiers: CR1010832013-000215-24
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of JNJ-54861911

  The maximal tolerated dose (MTD) after single dose administration of JNJ-54861911 or the safety and tolerability at the maximum feasible dose level, whichever is reached first

  Up to 96 hours

Secondary Outcomes (7)

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

  Up to 96 hours post-dose

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

  Up to 96 hours post-dose

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

  Up to 96 hours post-dose

• Half-life of JNJ-54861911

  Up to 96 hours post-dose

• Amyloid Beta profile in cerebrospinal fluid (CSF)

  Up to 36 hours post-dose

Study Arms (9)

Part 1 - Cohort 1: JNJ-54861911 1 mg

EXPERIMENTAL

Following each dose level the observed safety and tolerability profile will be evaluated. The dose will be escalated only if the observed safety and tolerability profile is acceptable.

Drug: JNJ-54861911 1mg

Part 1 - Cohort 2: JNJ-54861911 3 mg

EXPERIMENTAL

Drug: JNJ-54861911 3 mg

Part 1 - Cohort 3: JNJ-54861911 9 mg

EXPERIMENTAL

Drug: JNJ-54861911 9 mg

Part 2 - Cohort 4: JNJ-54861911 9 mg

EXPERIMENTAL

Drug: JNJ-54861911 9 mg

Part 2 - Cohort 5: JNJ-54861911 27 mg

EXPERIMENTAL

Drug: JNJ-54861911 27 mg

Part 2 - Cohort 6: JNJ-54861911 81 mg

EXPERIMENTAL

Drug: JNJ-54861911 81 mg

Part 2 - Cohort 7: JNJ-54861911 160 mg

EXPERIMENTAL

Drug: JNJ-54861911 160 mg

Part 3 - Cohort 8: JNJ-54861911 (dose to be determined [tbd])

EXPERIMENTAL

Drug: JNJ-54861911 tbd

Parts 1 through 3 - Placebo

PLACEBO COMPARATOR

Participants in each cohort will receive matching placebo.

Drug: Placebo

Interventions

JNJ-54861911 1mg DRUG

JNJ-54861911 1 mg will be administered as a single oral dose after an overnight fast of at least 10 hours.

Part 1 - Cohort 1: JNJ-54861911 1 mg

JNJ-54861911 3 mg DRUG

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

Part 1 - Cohort 2: JNJ-54861911 3 mg

JNJ-54861911 9 mg DRUG

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

Part 1 - Cohort 3: JNJ-54861911 9 mg

JNJ-54861911 27 mg DRUG

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

Part 2 - Cohort 5: JNJ-54861911 27 mg

JNJ-54861911 81 mg DRUG

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

Part 2 - Cohort 6: JNJ-54861911 81 mg

JNJ-54861911 160 mg DRUG

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

Part 2 - Cohort 7: JNJ-54861911 160 mg

JNJ-54861911 tbd DRUG

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

Part 3 - Cohort 8: JNJ-54861911 (dose to be determined [tbd])

Placebo DRUG

Matching placebo will be given as a single oral dose.

Parts 1 through 3 - Placebo

Eligibility Criteria

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

You may qualify if:

• Good general health
• Must adhere to required contraception during and for 3 months after study
• Body mass index between 18 and 30 kg/m2
• Male volunteers, between 18 and 54 years of age, inclusive
• 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
• Male volunteers

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
• History or family history of spontaneous, prolonged or severe bleeding of unclear origin or of blood clotting
• Current anemia
• 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

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: April 5, 2013
• First Posted: April 10, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

BE (1)