A Safety, Tolerability and Pharmacokinetics Study of JNJ-54861911 in Healthy Japanese Male Participants

NCT02180269 | Completed Phase 1

• 2 other identifiers: CR10461454861911ALZ1006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK, study of the way a drug enters and leaves the blood and tissues over time) of single-ascending oral doses of JNJ-54861911 in healthy Japanese male participants.

Conditions

Healthy

Keywords

Healthy; JNJ-54861911; Alzheimer's disease

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose administration, that were absent before treatment or that worsened relative to pretreatment state.

  Screening up to 14 days after last dose administration or early withdrawal

• Maximum Plasma Concentration (Cmax)

  The Cmax is the maximum observed plasma concentration.

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1

• Time to Reach Maximum Concentration (Tmax)

  The Tmax is time to reach the maximum observed plasma concentration.

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

  The AUC (0-last) is area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (Clast).

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1

• Apparent Clearance (CL/F)

  Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1

Secondary Outcomes (2)

• Cerebrospinal Fluid (CSF) Amyloid-Beta Concentration

  24 hours pre-administration of drug on Day -1, 24 hours post-administration of drug on Day 2

• Plasma Amyloid-Beta Concentration

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1

Study Arms (3)

Cohort A

EXPERIMENTAL

Single oral dose of either JNJ-54861911, 25 milligram (mg) tablet or matched placebo tablet on Day 1.

Drug: JNJ-54861911 (25 mg); Drug: Placebo

Cohort B

EXPERIMENTAL

Single oral dose of either JNJ-54861911, 50 mg (2\*25 mg tablets) or matched placebo tablets on Day 1.

Drug: JNJ-54861911 (50 mg); Drug: Placebo

Cohort C

EXPERIMENTAL

Single oral dose of either JNJ-54861911, 100 mg (4\*25 mg tablets) or matched placebo tablets on Day 1.

Drug: JNJ-54861911 (100 mg); Drug: Placebo

Interventions

JNJ-54861911 (25 mg) DRUG

Single oral dose of JNJ-54861911, 25 mg on Day 1.

Cohort A

JNJ-54861911 (50 mg) DRUG

Single oral dose of JNJ-54861911, 50 mg on Day 1.

Cohort B

JNJ-54861911 (100 mg) DRUG

Single oral dose of JNJ-54861911, 100 mg on Day 1.

Cohort C

Placebo DRUG

Single oral dose of placebo matched to JNJ-54861911 on Day 1.

Cohort A; Cohort B; Cohort C

Eligibility Criteria

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

You may qualify if:

• Signed an informed consent document indicating they understand the purpose of and procedures required for the study, and are willing to participate in the study
• A man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator, and must not donate sperm during the study and for 90 days after receiving the study drug
• Body mass index between 18 and 30 kilogram (kg) per square meter
• Blood pressure (supine for 5 minutes) between 90 and 150 millimeter of mercury (mm Hg) systolic, and no higher than 90 mm Hg diastolic
• Must be healthy on the basis of physical and neurological examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening or admission (up to Day 1 predose)

You may not qualify if:

• History of or current liver or renal impairment, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, dermatological (at the puncture site) or metabolic disturbances
• History of spontaneous, prolonged and severe bleeding of unclear origin
• History of epilepsy or fits
• History of human immunodeficiency virus (HIV) antigen/antibody positive, or tests positive for HIV at screening

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Fukuoka, Japan

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 Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

JP (1)