Back to resultsA Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3303560 - IV
Saline Solution - IV
LY3303560 - SC
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease
Eligibility Criteria
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)
Sites / Locations
- Parexel Early Phase Unit at Glendale
- PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
LY3303560
Saline Solution
LY3303560 Subcutaneous (SC)
Arm Description
Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants.
Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants.
Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants.
Outcomes
Primary Outcome Measures
Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Secondary Outcome Measures
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560
Serum PK: AUC. Statistical analysis was not pre-specified.
PK: Maximum Drug Concentration (Cmax) of LY3303560
Serum PK: Cmax. Statistical analysis was not pre-specified.
Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD)
Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD)
Mean Change From Baseline in QT/QT Corrected (QTc) Interval
Mean change from baseline in QT/QTc intervals using Fridericia's formula [Fridericia's corrected QT(QTcF)] from ECG monitoring.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02754830
Brief Title
A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 70 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3303560
Arm Type
Experimental
Arm Description
Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants.
Arm Title
Saline Solution
Arm Type
Placebo Comparator
Arm Description
Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants.
Arm Title
LY3303560 Subcutaneous (SC)
Arm Type
Experimental
Arm Description
Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants.
Intervention Type
Drug
Intervention Name(s)
LY3303560 - IV
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Saline Solution - IV
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
LY3303560 - SC
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration
Description
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame
Baseline up to 146 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560
Description
Serum PK: AUC. Statistical analysis was not pre-specified.
Time Frame
Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose
Title
PK: Maximum Drug Concentration (Cmax) of LY3303560
Description
Serum PK: Cmax. Statistical analysis was not pre-specified.
Time Frame
Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose
Title
Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD)
Time Frame
Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose
Title
Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD)
Time Frame
Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose
Title
Mean Change From Baseline in QT/QT Corrected (QTc) Interval
Description
Mean change from baseline in QT/QTc intervals using Fridericia's formula [Fridericia's corrected QT(QTcF)] from ECG monitoring.
Time Frame
Baseline, 7 days postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Parexel Early Phase Unit at Glendale
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trials.lilly.com/ext/trial?id=I8G-MC-LMDA
Description
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