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Trial record 2 of 3 for:    CNP520

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

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ClinicalTrials.gov Identifier: NCT02576639
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : May 25, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CNP520 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : August 10, 2015
Actual Primary Completion Date : March 11, 2016
Actual Study Completion Date : March 11, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
Drug: Placebo
Matching placebo to CNP520 was supplied in capsules.

Experimental: CNP520 2 mg
CNP520 2 mg was taken qd orally for 13 weeks.
Drug: CNP520
Other Name: CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.

Experimental: CNP520 10 mg
CNP520 10 mg was taken qd orally for 13 weeks.
Drug: CNP520
Other Name: CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.

Experimental: CNP520 35 mg
CNP520 35 mg was taken qd orally for 13 weeks.
Drug: CNP520
Other Name: CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.

Experimental: CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
Drug: CNP520
Other Name: CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.




Primary Outcome Measures :
  1. Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths [ Time Frame: 13 weeks ]
    Safety monitoring was conducted throughout the study.


Secondary Outcome Measures :
  1. Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations [ Time Frame: Day 92 ]
    CSF samples were collected by lumbar puncture for assessment.

  2. Summary of Plasma PK Parameter: Cmax [ Time Frame: Days 1, 91 ]
    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.

  3. Summary of Plasma PK Parameter: AUCtau [ Time Frame: Days 1 and 91 ]
    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.

  4. Summary of Plasma PK Parameter: Tmax [ Time Frame: Days 1 and 91 ]
    Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.

  5. Summary of Plasma PK Parameter: Tlag [ Time Frame: Days 1 and 91 ]
    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.

  6. Summary of Plasma PK Parameter: T1/2 [ Time Frame: Day 91 ]
    T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.

  7. Summary of PK Parameter: CLss/F [ Time Frame: Day 91 ]
    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.

  8. Summary of Plasma PK Parameter: Racc [ Time Frame: Day 91 ]
    Racc = the accumulation ratio . Blood samples were collected to assess Racc.

  9. Summary of CSF PK Concentrations [ Time Frame: Days 1, 14, 28, 42, 56, 70 and 91 ]
    CSF samples were collected by lumbar puncture for assessment.

  10. Area-under-plasma Concentration Time Curve up to Infinity (AUCinf) [ Time Frame: Day 91 ]
    CNP520 concentrations in plasma

  11. Apparent Volume of Distribution (Vz/F) [ Time Frame: Day 91 ]


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576639


Locations
United States, California
Novartis Investigative Site
Glendale, California, United States, 91206
Novartis Investigative Site
Long Beach, California, United States, 90806
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33126
United States, Nebraska
Novartis Investigative Site
Lincoln, Nebraska, United States, 68502
Belgium
Novartis Investigative Site
Antwerpen, Belgium, 2060
Germany
Novartis Investigative Site
Berlin, Germany, 14050
Netherlands
Novartis Investigative Site
Groningen, GZ, Netherlands, 9713
Novartis Investigative Site
Leiden, Netherlands, 2333 CL
United Kingdom
Novartis Investigative Site
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Novartis Investigative Site
Harrow, United Kingdom, HA1 3UJ
Novartis Investigative Site
Mid Glamorgan, United Kingdom, CF484DR
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Study Director Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02576639     History of Changes
Other Study ID Numbers: CCNP520X2102
2013-005576-18 ( EudraCT Number )
First Posted: October 15, 2015    Key Record Dates
Results First Posted: May 25, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Alzheimer's Disease,
Amyloid Beta,
cerebrospinal fluid,
beta secretase

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders