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

Healthy Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized, Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Japanese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180269
• Other study ID #: CR104614
• Secondary ID: 54861911ALZ1006
• Status: Completed
• Phase: Phase 1
• First received: July 1, 2014
• Last updated: September 11, 2014
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-center, randomized (study medication assigned to participants by chance), double-blind (neither Investigator nor participant knows which treatment the participant receives), placebo controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), study of a single-ascending dose of JNJ-54861911 in participants between 55 to 75 years of age. The duration of study will be approximately 2 to 6 weeks per participant. The study consists of 3 periods: Screening period (28 to 2 days prior to dose administration); Double-blind Treatment period (participants will receive either a single oral dose of JNJ-54861911 or placebo as tablets under fasted conditions); and a Follow-up visit period (7 to 14 days after dose administration). All the eligible participants will be assigned to any of following 3 cohorts: Cohort A (single oral dose of JNJ-54861911, 25 milligram [mg] or placebo); Cohort B (single oral dose of JNJ-54861911, 50 mg or placebo); Cohort C (single oral dose of JNJ-54861911, 100 mg or placebo). Each cohort will include 8 participants. Participants in each cohort will be randomly assigned to receive either a single oral dose of JNJ-54861911 (n = 6) or placebo (n = 2). Blood samples will be collected pre-dose and over 96 hours (that is up to Day 5) after dosing for understanding the PK characteristics of JNJ-54861911. Participants' safety will be monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-54861911 (25 mg)
Single oral dose of JNJ-54861911, 25 mg on Day 1.
• JNJ-54861911 (50 mg)
Single oral dose of JNJ-54861911, 50 mg on Day 1.
• JNJ-54861911 (100 mg)
Single oral dose of JNJ-54861911, 100 mg on Day 1.
• Placebo
Single oral dose of placebo matched to JNJ-54861911 on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Cerebrospinal Fluid (CSF) Amyloid-Beta Concentration	Amyloid-beta (biomarker, supposed to be a key feature in the pathogenesis of Alzheimer's disease) levels in CSF will be explored.	24 hours pre-administration of drug on Day -1, 24 hours post-administration of drug on Day 2	No
Secondary	Plasma Amyloid-Beta Concentration	Amyloid-beta (biomarker, supposed to be a key feature in the pathogenesis of Alzheimer's disease) levels in plasma will be explored.	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	No