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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02933762
• Date of registration: 21/09/2016
• Prospective Registration: No
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma
• Scientific 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
• Date of first enrolment: September 2016
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02933762
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: JNJ-54175446

Drug: Placebo

Primary Outcome(s)

Minimum Observed Plasma Concentration (Cmin)During Dosing Interval [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]

The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood [Time Frame: Part 2: Up 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]

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]

The Effects of JNJ-54175446 (Dose Response) on Levels of Aß Fragments in Plasma [Time Frame: Part 1: Up to Day 2]

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]

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]

The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood [Time Frame: Part 1: Up to Day 2]

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]

The Effects of JNJ-54175446 (Dose Response) on Levels of Aß 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 CSF [Time Frame: Part 1: Up to Day 2]

The Effects of JNJ-54175446 (Dose Response) on Levels of Aß Fragments in Cerebrospinal Fluid (CSF) [Time Frame: Part 1: Up to Day 2]

The Effects of JNJ-54175446 (Dose Response) on Levels of Aß Fragments in Plasma [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 2: Up 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]

Secondary Outcome(s)

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])]

Secondary ID(s)

CR108231

2016-003040-37

54175446EDI1005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors