NCT02933762

Brief Summary

The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro) inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by single and multiple dose administration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

September 21, 2016

Last Update Submit

January 31, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (16)

  • The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma

    Part 1: Up to Day 2

  • The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma

    Part 2: Up to Day 8

  • The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)

    Part 1: Up to Day 2

  • The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)

    Part 2: Up to Day 8

  • The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood

    Part 1: Up to Day 2

  • The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood

    Part 2: Up to Day 8

  • The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF

    Part 1: Up to Day 2

  • The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF

    Part 2: Up to Day 8

  • Maximum Observed Plasma Concentration (Cmax) After Single- and Multiple-Dose Administration

    Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8

  • Minimum Observed Plasma Concentration (Cmin)During Dosing Interval

    Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8

  • The Observed Plasma Concentration Just Prior to the Beginning or at the end of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)

    Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8

  • Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg)

    Part 1: Day 1 - Day 2; Par 2: Day 1, Day 2 to 6, Day 7, Day 8

  • Time to Reach the Maximum Plasma Concentration, After Single- and Multiple-Dose Administration (Tmax)

    Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8

  • Area Under The Concentration-Time Curve From 0 To t Hours Postdosing (AUCt)

    Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8

  • Area Under the Concentration-Time Curve From 0 to 24 Hours Postdosing (AUC24h)

    Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8

  • The Ratio of the Maximum Plasma Concentration (Peak) to Trough Observed Concentration (Peak/Trough Ratio)

    Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8

Secondary Outcomes (1)

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Screening up to follow-up (in part 1 and part 2 [approximately up to 8 weeks])

Study Arms (13)

Part 1: Cohort A1 (JNJ-54175446 30 milligram[mg])

EXPERIMENTAL

Healthy elderly participants will receive single dose of 30mg JNJ-54175446.

Drug: JNJ-54175446

Part 1: Cohort A1 (JNJ-54175446 100mg)

EXPERIMENTAL

Healthy elderly participants will receive single dose of 100mg JNJ-54175446.

Drug: JNJ-54175446

Part 1: Cohort A1 (JNJ-54175446 300mg)

EXPERIMENTAL

Healthy elderly participants will receive single dose of 300mg JNJ-54175446.

Drug: JNJ-54175446

Part 1: Cohort A1 (Placebo)

EXPERIMENTAL

Healthy elderly participants will receive single dose of placebo.

Drug: Placebo

Part 1: Cohort A2 (JNJ-54175446 D1 mg)

EXPERIMENTAL

Healthy elderly participants will receive an additional dose D1 mg \[less than or equal to (\<=) 600 mg\] of JNJ-54175446, to be determined.

Drug: JNJ-54175446

Part 1: Cohort A3 (JNJ-54175446 D2 mg)

EXPERIMENTAL

Healthy young participants will receive a single dose D2 mg (\<= 600 mg) of JNJ-54175446, to be determined.

Drug: JNJ-54175446

Part 1: Cohort A3 (Placebo)

EXPERIMENTAL

Healthy young participants will receive a single dose of placebo.

Drug: Placebo

Part 2: Cohort B1 (JNJ-54175446 D3 mg)

EXPERIMENTAL

Healthy elderly participants will receive multiple dose levels D3 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.

Drug: JNJ-54175446

Part 2: Cohort B1 (Placebo)

EXPERIMENTAL

Healthy elderly participants will receive placebo determined based on the results from Cohort A1.

Drug: Placebo

Part 2: Cohort B2 (JNJ-54175446 D4 mg)

EXPERIMENTAL

Healthy elderly participants will receive multiple dose levels D4 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.

Drug: JNJ-54175446

Part 2: Cohort B2 (Placebo)

EXPERIMENTAL

Healthy elderly participants will receive placebo determined based on the results from Cohort A1

Drug: Placebo

Part 2: Cohort B3 (JNJ-54175446 D5 mg)

EXPERIMENTAL

Healthy elderly participants will receive multiple dose levels D5 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.

Drug: JNJ-54175446

Part 2: Cohort B3 (Placebo)

EXPERIMENTAL

Healthy elderly participants will receive placebo determined based on the results from Cohort A1

Drug: Placebo

Interventions

JNJ-54175446DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 1: Cohort A1 (JNJ-54175446 100mg)Part 1: Cohort A1 (JNJ-54175446 30 milligram[mg])Part 1: Cohort A1 (JNJ-54175446 300mg)Part 1: Cohort A2 (JNJ-54175446 D1 mg)Part 1: Cohort A3 (JNJ-54175446 D2 mg)Part 2: Cohort B1 (JNJ-54175446 D3 mg)Part 2: Cohort B2 (JNJ-54175446 D4 mg)Part 2: Cohort B3 (JNJ-54175446 D5 mg)
PlaceboDRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 1: Cohort A1 (Placebo)Part 1: Cohort A3 (Placebo)Part 2: Cohort B1 (Placebo)Part 2: Cohort B2 (Placebo)Part 2: Cohort B3 (Placebo)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have a body mass index (BMI) between 18 and 32 kilogram (kg)/ meter (m)\^2, inclusive (BMI = weight/height\^2)
  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG)
  • Part 1 and 2 (Elderly Participants):
  • Healthy male or female participants between 55 and 75 years of age, inclusive
  • Participant must be healthy on the basis of both physical and neurological examination performed at Screening and at admission to the clinical unit
  • Part 1 (Young Participants):
  • \- Healthy male participants between 18 and 45 years of age, inclusive

You may not qualify if:

  • Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the participant
  • Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening (per Screening evaluations)
  • Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening (per Screening evaluations)
  • Participant has a history of malignancy within 5 years before Screening
  • Participant has signs of increased intracranial pressure based on fundoscopy at Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Related Publications (1)

  • Triana-Baltzer G, Timmers M, De Boer P, Schoene M, Furey M, Bleys C, Vrancken I, Slemmon R, Ceusters M, van Nueten L, Kolb H. Profiling classical neuropsychiatric biomarkers across biological fluids and following continuous lumbar puncture: A guide to sample type and time. Compr Psychoneuroendocrinol. 2022 Jan 15;10:100116. doi: 10.1016/j.cpnec.2022.100116. eCollection 2022 May.

    PMID: 35774109DERIVED

MeSH Terms

Interventions

JNJ-54175446

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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

October 14, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

BE(1)