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A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease
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.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2013-03 |
| Completion | 2013-05 |
Conditions
- Alzheimer Disease
- Healthy Volunteers
Interventions
- LY2886721
- Placebo
Primary outcomes
- Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 — Predose through 96 hours after administration of study drug
AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721. - Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 — Predose through 96 hours after administration of study drug
Cmax following administration of a single dose of 70 or 280 mg LY2886721. - Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721 — Predose through 36 hours after administration of study drug
AUC0-∞ following administration of a single dose of 70 mg LY2886721. - Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 — Predose through 36 hours after administration of study drug
Cmax following administration of a single dose of 70 mg LY2886721. - Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 — Predose, up to 96 hours after administration of study drug
Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir). - PD: Cnadir of CSF Aβ 1-40 — Predose up to 36 hours after administration of study drug
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.
Countries
United States