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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CNP520
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease focused on measuring Alzheimer's Disease,, Amyloid Beta,, cerebrospinal fluid,, beta secretase

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

CNP520 2 mg

CNP520 10 mg

CNP520 35 mg

CNP520 85 mg

Arm Description

Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.

CNP520 2 mg was taken qd orally for 13 weeks.

CNP520 10 mg was taken qd orally for 13 weeks.

CNP520 35 mg was taken qd orally for 13 weeks.

CNP520 85 mg was taken qd orally for 13 weeks.

Outcomes

Primary Outcome Measures

Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Safety monitoring was conducted throughout the study.

Secondary Outcome Measures

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.
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.
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.
Summary of Plasma PK Parameter: Tmax
Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.
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.
Summary of Plasma PK Parameter: T1/2
T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.
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.
Summary of Plasma PK Parameter: Racc
Racc = the accumulation ratio . Blood samples were collected to assess Racc.
Summary of CSF PK Concentrations
CSF samples were collected by lumbar puncture for assessment.
Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)
CNP520 concentrations in plasma
Apparent Volume of Distribution (Vz/F)

Full Information

First Posted
August 18, 2015
Last Updated
August 7, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02576639
Brief Title
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 10, 2015 (Actual)
Primary Completion Date
March 11, 2016 (Actual)
Study Completion Date
March 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease,, Amyloid Beta,, cerebrospinal fluid,, beta secretase

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
Arm Title
CNP520 2 mg
Arm Type
Experimental
Arm Description
CNP520 2 mg was taken qd orally for 13 weeks.
Arm Title
CNP520 10 mg
Arm Type
Experimental
Arm Description
CNP520 10 mg was taken qd orally for 13 weeks.
Arm Title
CNP520 35 mg
Arm Type
Experimental
Arm Description
CNP520 35 mg was taken qd orally for 13 weeks.
Arm Title
CNP520 85 mg
Arm Type
Experimental
Arm Description
CNP520 85 mg was taken qd orally for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
CNP520
Other Intervention Name(s)
CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to CNP520 was supplied in capsules.
Primary Outcome Measure Information:
Title
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Description
Safety monitoring was conducted throughout the study.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
Description
CSF samples were collected by lumbar puncture for assessment.
Time Frame
Day 92
Title
Summary of Plasma PK Parameter: Cmax
Description
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
Title
Summary of Plasma PK Parameter: AUCtau
Description
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
Title
Summary of Plasma PK Parameter: Tmax
Description
Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.
Time Frame
Days 1 and 91
Title
Summary of Plasma PK Parameter: Tlag
Description
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
Title
Summary of Plasma PK Parameter: T1/2
Description
T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.
Time Frame
Day 91
Title
Summary of PK Parameter: CLss/F
Description
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
Title
Summary of Plasma PK Parameter: Racc
Description
Racc = the accumulation ratio . Blood samples were collected to assess Racc.
Time Frame
Day 91
Title
Summary of CSF PK Concentrations
Description
CSF samples were collected by lumbar puncture for assessment.
Time Frame
Days 1, 14, 28, 42, 56, 70 and 91
Title
Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)
Description
CNP520 concentrations in plasma
Time Frame
Day 91
Title
Apparent Volume of Distribution (Vz/F)
Time Frame
Day 91

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Novartis Investigative Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
Facility Name
Novartis Investigative Site
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Novartis Investigative Site
City
Groningen
State/Province
GZ
ZIP/Postal Code
9713
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Leiden
ZIP/Postal Code
2333 CL
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 6AD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Mid Glamorgan
ZIP/Postal Code
CF484DR
Country
United Kingdom

12. IPD Sharing Statement

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

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