A Study of LY2886721 in Healthy Participants
- Registration Number
- NCT01534273
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate the drug's effect on the body.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Healthy men and non-childbearing potential women
- Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m^2)
- Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies
- Taking over-the-counter or prescription medication with the exception of vitamins or minerals
- Smoke more than 10 cigarettes per day
- Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Single oral dose and/or once daily (QD) oral dosing for 14 consecutive days 35 mg LY2886721 LY2886721 QD oral dosing for 14 consecutive days 70 mg LY2886721 LY2886721 Single oral dose or single oral dose followed by QD oral dosing for 14 consecutive days 140 mg LY2886721 LY2886721 Single oral dose
- Primary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Effects Predose up to Day 23 Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Plasma Maximum Observed Concentration (Cmax) of LY2886721 Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of LY2886721 Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Pharmacokinetics: Plasma Maximum Observed Concentration at Steady State (Cmax,ss) of LY2886721 Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose AUC over the dosing interval at steady state (AUCtau,ss) is reported for participants who received multiple doses of LY2886721.
Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at Day 15 Baseline, Day 15 Least squares (LS) mean percent changes from baseline to Day 15 in CSF amyloid 1-40 concentrations for participants in Cohort B are reported. LS means were calculated from an analysis of covariance (ANCOVA) with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% confidence interval (CI) of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline.
Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at 24 Hours Post-dose Baseline, 24 hours post-dose LS mean percent changes from baseline to 24 hours post-dose in CSF amyloid 1-40 concentrations for participants in Cohort C are reported. LS means were calculated from an ANCOVA with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% CI of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline.
Trial Locations
- Locations (1)
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.
🇺🇸Glendale, California, United States