Merksem, Belgium
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugParticipants 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
DrugParticipants 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
-
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma
Time frame: Part 1: Up to Day 2
-
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma
Time frame: Part 2: Up to Day 8
-
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)
Time frame: Part 1: Up to Day 2
-
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)
Time frame: Part 2: Up to Day 8
-
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood
Time frame: Part 1: Up to Day 2
-
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood
Time frame: Part 2: Up to Day 8
-
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF
Time frame: Part 1: Up to Day 2
-
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF
Time frame: Part 2: Up to Day 8
-
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
-
Minimum Observed Plasma Concentration (Cmin)During Dosing Interval
Time frame: 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)
Time frame: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
-
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
-
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
-
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
-
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
-
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
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Tumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsAI Chatbot for HPV Vaccine Literacy Among Caregivers in Japan
NCT06702423
Healthy
London, United Kingdom
View Trial DetailsValidation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
NCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNormative Value for Navicular Drop Test in Older Adults
NCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details