The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
124
Novartis Investigative Site
Glendale, California, United States
Novartis Investigative Site
Long Beach, California, United States
Novartis Investigative Site
Miami, Florida, United States
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Safety monitoring was conducted throughout the study.
Time frame: 13 weeks
Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
CSF samples were collected by lumbar puncture for assessment.
Time frame: Day 92
Summary of Plasma PK Parameter: Cmax
Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis.
Time frame: Days 1, 91
Summary of Plasma PK Parameter: AUCtau
AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau.
Time frame: Days 1 and 91
Summary of Plasma PK Parameter: Tmax
Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.
Time frame: Days 1 and 91
Summary of Plasma PK Parameter: Tlag
Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag.
Time frame: Days 1 and 91
Summary of Plasma PK Parameter: T1/2
T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.
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Novartis Investigative Site
Lincoln, Nebraska, United States
Novartis Investigative Site
Antwerp, Belgium
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Groningen, GZ, Netherlands
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Belfast, Northern Ireland, United Kingdom
Novartis Investigative Site
Harrow, United Kingdom
...and 1 more locations
Time frame: Day 91
Summary of PK Parameter: CLss/F
CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F.
Time frame: Day 91
Summary of Plasma PK Parameter: Racc
Racc = the accumulation ratio . Blood samples were collected to assess Racc.
Time frame: Day 91
Summary of CSF PK Concentrations
CSF samples were collected by lumbar puncture for assessment.
Time frame: Days 1, 14, 28, 42, 56, 70 and 91
Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)
CNP520 concentrations in plasma
Time frame: Day 91
Apparent Volume of Distribution (Vz/F)
Time frame: Day 91