This study is being done for the following reasons: To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It will also look at how safe and tolerable the study drug is when given to healthy participants in higher doses. This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C. Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants. For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
36
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Salt Lake City, Utah, United States
Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721
AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.
Time frame: Predose through 96 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721
Cmax following administration of a single dose of 70 or 280 mg LY2886721.
Time frame: Predose through 96 hours after administration of study drug
Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721
AUC0-∞ following administration of a single dose of 70 mg LY2886721.
Time frame: Predose through 36 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721
Cmax following administration of a single dose of 70 mg LY2886721.
Time frame: Predose through 36 hours after administration of study drug
Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40
Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).
Time frame: Predose, up to 96 hours after administration of study drug
PD: Cnadir of CSF Aβ 1-40
Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.
Time frame: Predose up to 36 hours after administration of study drug
Cohort C: Mean QTcF Value at Cmax
The mean QTcF value at Cmax for participants administered a single dose of 280 mg LY2886721 was reported. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Time matched mean change from baseline in QTcF = time matched plasma concentration + participant + random error.
Time frame: Predose up to 48 hours after administration of study drug
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