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Completed

NCT Number: NCT02576639

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Tauopathies

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CNP520

Drug

Other names: CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.

Placebo

Drug

Matching placebo to CNP520 was supplied in capsules.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 15, 2015
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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