Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of CNP520 in Healthy Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576639
• Other study ID #: CCNP520X2102
• Secondary ID: 2013-005576-18
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2015
• Last updated: August 7, 2017
• Start date: August 10, 2015
• Est. completion date: March 11, 2016

Study information

• Verified date: August 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 11, 2016
• Est. primary completion date: March 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Key Inclusion Criteria:

• Healthy status

• Body weight: =45kg

• BMI: 18-34 kg/m2

Key Exclusion Criteria:

• History or presence of any clinically significant disease of any major system organ class.

• Heavy smoker status

• History /presence of clinically significant neurological or psychiatric disorders

• Any medical condition that might lead to or is associated with any cognitive deficit

• History or presence of severely impaired renal function

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• CNP520

• Placebo
Matching placebo to CNP520 was supplied in capsules.

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Antwerpen
Germany	Novartis Investigative Site	Berlin
Netherlands	Novartis Investigative Site	Groningen	GZ
Netherlands	Novartis Investigative Site	Leiden
United Kingdom	Novartis Investigative Site	Belfast	Northern Ireland
United Kingdom	Novartis Investigative Site	Harrow
United Kingdom	Novartis Investigative Site	Mid Glamorgan
United States	Novartis Investigative Site	Glendale	California
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths	Safety monitoring was conducted throughout the study.	13 weeks
Secondary	Change From Baseline of Amyloid Beta (Aß) 1-38 , Aß 1-40 and Aß 1-42 Cerebrospinal Fluid (CSF) Concentrations	CSF samples were collected by lumbar puncture for assessment.	Day 92
Secondary	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.	Days 1, 91
Secondary	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.	Days 1 and 91
Secondary	Summary of Plasma PK Parameter: Tmax	Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.	Days 1 and 91
Secondary	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.	Days 1 and 91
Secondary	Summary of Plasma PK Parameter: T1/2	T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.	Day 91
Secondary	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.	Day 91
Secondary	Summary of Plasma PK Parameter: Racc	Racc = the accumulation ratio . Blood samples were collected to assess Racc.	Day 91
Secondary	Summary of CSF PK Concentrations	CSF samples were collected by lumbar puncture for assessment.	Days 1, 14, 28, 42, 56, 70 and 91
Secondary	Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)	CNP520 concentrations in plasma	Day 91
Secondary	Apparent Volume of Distribution (Vz/F)		Day 91

External Links

•   Results for CCNP520X2102 from the Novartis Clinical Trial Results Website