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History of Changes for Study: NCT02576639
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
Latest version (submitted August 7, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 13, 2015 None (earliest Version on record)
2 April 26, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 May 3, 2016 Study Status and Study Design
4 April 20, 2017 Study Status, Outcome Measures, Arms and Interventions, Results, Contacts/Locations, Study Design and Study Description
5 August 7, 2017 Study Status
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Study NCT02576639
Submitted Date:  October 13, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: CCNP520X2102
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
Secondary IDs: 2013-005576-18 [EudraCT Number]
Open or close this module Study Status
Record Verification: October 2015
Overall Status: Recruiting
Study Start: August 2015
Primary Completion: March 2016 [Anticipated]
Study Completion: March 2016 [Anticipated]
First Submitted: August 18, 2015
First Submitted that
Met QC Criteria:
October 13, 2015
First Posted: October 15, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 13, 2015
Last Update Posted: October 15, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The study will determine the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling will be obtained in order to define the target dose in subsequent efficacy studies.
Detailed Description:
Open or close this module Conditions
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease,
Amyloid Beta,
cerebrospinal fluid,
beta secretase
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 5
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 125 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: CNP520 Dose 1
25 healthy elderly subjects will be enrolled
Drug: CNP520
CNP520 will be taken oral, once-daily for 13 weeks
Experimental: CNP520 Dose 2
25 healthy elderly subjects will be enrolled
Drug: CNP520
CNP520 will be taken oral, once-daily for 13 weeks
Experimental: CNP520 Dose 3
25 healthy elderly subjects will be enrolled
Drug: CNP520
CNP520 will be taken oral, once-daily for 13 weeks
Experimental: CNP520 Dose 4
25 healthy elderly subjects will be enrolled
Drug: CNP520
CNP520 will be taken oral, once-daily for 13 weeks
Placebo Comparator: Placebo
25 healthy elderly subjects will be enrolled
Drug: Placebo
The study is placebo controlled
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of patients with adverse events, serious adverse events and deaths
[ Time Frame: Date of enrollment until about 30 days after last dose ]

Adverse event and will be evaluated with respect to multiple aspects including incidence, time course, severity, relationship to drug intake etc. Other safety data will be primarily evaluated with respect to out-of-range values and trends over time
Secondary Outcome Measures:
1. Change from baseline of Aβ, Aβ 1-40 and Aβ 1-42 concentrations in CSF
[ Time Frame: Predose through study completion (6months) ]

Change from baseline of Aβ concentrations in CSF
2. CNP520 concentrations in CSF
[ Time Frame: Predose through study completion (6months) ]

This outcome measures the CNP520 concentrations in CSF
3. Peak plasma concentration (Cmax)
[ Time Frame: Predose through study completion (6months) ]

CNP520 concentrations in plasma
4. Area-under-plasma concentration time curve up to infinity (AUCinf)
[ Time Frame: Predose through study completion (6months) ]

CNP520 concentrations in plasma
5. Area-under-plasma concentration time curve during dosing interval (AUCtau)
[ Time Frame: Predose through study completion (6months) ]

CNP520 concentrations in plasma
6. Terminal elimination half-life (T1/2)
[ Time Frame: Predose through study completion (6months) ]

CNP520 concentrations in plasma
7. Apparent volume of distribution (Vz/F)
[ Time Frame: Predose through study completion (6months) ]

8. Apparent oral clearance (Cl/F)
[ Time Frame: Predose through study completion (6months) ]

Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Novartis Pharmaceuticals
Telephone: 1-888-669-6682
Central Contact Backup: Novartis Pharmaceuticals
Study Officials: Study Director
Study Director
Novartis Pharmaceuticals
Locations: United States, California
Novartis Investigative Site
[Recruiting]
Glendale, California, United States, 91206
Novartis Investigative Site
[Recruiting]
Long Beach, California, United States, 90806
United States, Florida
Novartis Investigative Site
[Recruiting]
Miami, Florida, United States, 33126
United States, Nebraska
Novartis Investigative Site
[Recruiting]
Lincoln, Nebraska, United States, 68502
Belgium
Novartis Investigative Site
[Recruiting]
Antwerpen, Belgium, 2060
Germany
Novartis Investigative Site
[Recruiting]
Berlin, Germany, 14050
Netherlands, AG
Novartis Investigative Site
[Recruiting]
Groningen, AG, Netherlands, 9713
United Kingdom
Novartis Investigative Site
[Recruiting]
Mid Glamorgan, United Kingdom, CF484DR
United Kingdom, Northern Ireland
Novartis Investigative Site
[Recruiting]
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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