Clinical Trial: A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official 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 Amylo
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.
Detailed Summary:
Sponsor: Janssen Research & Development, LLC
Current Primary Outcome:
- 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 Pr
Original Primary Outcome: Same as current
Current Secondary Outcome: 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]) ]
Original Secondary Outcome: Same as current
Information By: Janssen Research & Development, LLC
Dates:
Date Received: September 21, 2016
Date Started: September 2016
Date Completion:
Last Updated: January 13, 2017
Last Verified: January 2017