Clinical trial NCT02754830: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration
timeFrame: Baseline up to 146 days
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560
timeFrame: 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
measure: PK: Maximum Drug Concentration (Cmax) of LY3303560
timeFrame: 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
measure: Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD)
timeFrame: Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose
measure: Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD)
timeFrame: Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose
measure: Mean Change From Baseline in QT/QT Corrected (QTc) Interval
timeFrame: Baseline, 7 days postdose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel Early Phase Unit at Glendale
state: California
city: Baltimore
country: United States
facility: PAREXEL-Phase 1 Baltimore Harbor Hospital Center
state: Maryland
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: