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A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)

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: NCT02754830
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 26, 2016
First Posted Date  ICMJE April 28, 2016
Last Update Posted Date July 23, 2018
Actual Study Start Date  ICMJE April 25, 2016
Actual Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2016)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Predose through 85 days post administration of study drug ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02754830 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2016)
  • Pharmacokinetics (Serum): Area Under the Concentration Versus Time Curve from Time 0 to Infinity (AUC[0-∞]) of LY3303560 [ Time Frame: Predose through 85 days post administration of study drug ]
  • Pharmacokinetics (Serum): Maximum Drug Concentration (Cmax) of LY3303560 [ Time Frame: Predose through 85 days post administration of study drug ]
  • Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 [ Time Frame: Predose through 3 days post administration of study drug ]
  • Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 [ Time Frame: Predose through 3 days post administration of study drug ]
  • Mean Change from Baseline in QT/QT Corrected (QTc) Interval [ Time Frame: Baseline, through 7 days post administration of study drug ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Official Title  ICMJE Single-Dose, Dose-Escalation Study With LY3303560 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Subjects and Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
Brief Summary

The purpose of this study is to evaluate the safety and tolerability of the study drug, LY3303560. Side effects and laboratory results will be monitored. This study will involve single doses of LY3303560 administered intravenously (IV), meaning into a vein or subcutaneously (SC), meaning under the skin.

Screening is required within 28 days before the start of the study for healthy participants and within 42 days before the start of the study for AD participants. The study requires about 16 weeks of each participant's time including a 4 day clinical research unit (CRU) admission and 10 follow-up appointments.

This is the first time that this study drug is being given to participants. This study is for research purposes only, and is not intended to treat any medical condition.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: LY3303560 - IV
    Administered IV
  • Drug: Saline Solution - IV
    Administered IV
  • Drug: LY3303560 - SC
    Administered SC
Study Arms  ICMJE
  • Experimental: LY3303560
    Single IV infusion or SC injection of LY3303560 on Day 1
    Interventions:
    • Drug: LY3303560 - IV
    • Drug: LY3303560 - SC
  • Placebo Comparator: Saline Solution
    Single IV infusion of saline solution to match LY3303560 on Day 1
    Intervention: Drug: Saline Solution - IV
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: August 2, 2017)
110
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2016)
90
Actual Study Completion Date  ICMJE July 10, 2018
Actual Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overtly healthy males or females of non-childbearing potential and who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • AD participants must be at least 50 years of age and have diagnostic criteria consistent with either mild cognitive impairment due to AD or mild-to moderate AD and have a positive florbetapir positron emission tomography (PET) scan

Exclusion Criteria:

  • Have known allergies to LY3303560, related compounds or any components of the formulation, or history of significant atopy
  • Have an increased risk of seizures
  • For AD participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by magnetic resonance imaging (MRI)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02754830
Other Study ID Numbers  ICMJE 16120
I8G-MC-LMDA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date July 2018

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