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Completed

NCT Number: NCT02933762

A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

JNJ-54175446

Drug

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.

Placebo

Drug

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.

Primary outcomes

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

    Time frame: Part 1: Up to Day 2

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

    Time frame: Part 2: Up to Day 8

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

    Time frame: Part 1: Up to Day 2

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

    Time frame: Part 2: Up to Day 8

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

    Time frame: Part 1: Up to Day 2

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

    Time frame: Part 2: Up to Day 8

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

    Time frame: Part 1: Up to Day 2

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

    Time frame: Part 2: Up to Day 8

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

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

  10. Minimum Observed Plasma Concentration (Cmin)During Dosing Interval

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

  11. 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)

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

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

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

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

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

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

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

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

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

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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

An Exploratory, Single-Blind, Placebo-Controlled, Randomized, Single- and Multiple-Dose Pharmacodynamics Study in Healthy Subjects to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2016
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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