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Trial record 3 of 3 for:    CNP520 | Alzheimer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date  ICMJE August 18, 2015
First Posted Date  ICMJE October 15, 2015
Results First Submitted Date  ICMJE March 9, 2017
Results First Posted Date  ICMJE May 25, 2017
Last Update Posted Date August 11, 2017
Actual Study Start Date  ICMJE August 10, 2015
Actual Primary Completion Date March 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths [ Time Frame: 13 weeks ]
Safety monitoring was conducted throughout the study.
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Summary of Plasma PK Parameter: Racc [ Time Frame: Day 91 ]
    Racc = the accumulation ratio . Blood samples were collected to assess Racc.
  • 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.
  • Area-under-plasma Concentration Time Curve up to Infinity (AUCinf) [ Time Frame: Day 91 ]
    CNP520 concentrations in plasma
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: Day 91 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
  • 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
  • CNP520 concentrations in CSF [ Time Frame: Predose through study completion (6months) ]
    This outcome measures the CNP520 concentrations in CSF
  • Peak plasma concentration (Cmax) [ Time Frame: Predose through study completion (6months) ]
    CNP520 concentrations in plasma
  • Area-under-plasma concentration time curve up to infinity (AUCinf) [ Time Frame: Predose through study completion (6months) ]
    CNP520 concentrations in plasma
  • Area-under-plasma concentration time curve during dosing interval (AUCtau) [ Time Frame: Predose through study completion (6months) ]
    CNP520 concentrations in plasma
  • Terminal elimination half-life (T1/2) [ Time Frame: Predose through study completion (6months) ]
    CNP520 concentrations in plasma
  • Apparent volume of distribution (Vz/F) [ Time Frame: Predose through study completion (6months) ]
  • Apparent oral clearance (Cl/F) [ Time Frame: Predose through study completion (6months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: CNP520
    Other Name: CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.
  • Drug: Placebo
    Matching placebo to CNP520 was supplied in capsules.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
    Intervention: Drug: Placebo
  • Experimental: CNP520 2 mg
    CNP520 2 mg was taken qd orally for 13 weeks.
    Intervention: Drug: CNP520
  • Experimental: CNP520 10 mg
    CNP520 10 mg was taken qd orally for 13 weeks.
    Intervention: Drug: CNP520
  • Experimental: CNP520 35 mg
    CNP520 35 mg was taken qd orally for 13 weeks.
    Intervention: Drug: CNP520
  • Experimental: CNP520 85 mg
    CNP520 85 mg was taken qd orally for 13 weeks.
    Intervention: Drug: CNP520
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
124
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2015)
125
Actual Study Completion Date  ICMJE March 11, 2016
Actual Primary Completion Date March 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02576639
Other Study ID Numbers  ICMJE CCNP520X2102
2013-005576-18 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Novartis Pharmaceuticals
PRS Account Novartis
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP