Phase 1
N=40
A Safety Study of LY2886721 Single Doses in Healthy Subjects
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01133405 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Clinically Significant Effects (Adverse Events) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY2886721 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Effects (Adverse Events) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of LY2886721 |
1.9; 22.5; 18.2; 6.6; 41.6; 79.1 | — |
| SECONDARY Plasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC) |
NA; 311; 212; 144; 468; 926 | — |
| SECONDARY Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only) |
121; 80; 56; 35; 34; 36 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only) |
0.93; 5.99 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only) |
8080; 5650; 7150 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only) |
27; 121 | — |
Summary
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body.
Eligibility Criteria
Inclusion Criteria
- Healthy men and nonchild-bearing potential women
- 20 years or older
- Body mass index between 18-32 kilograms per square meter (kg/m^2)
Exclusion Criteria
- Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement
- Smoke more than 10 cigarettes per day
Data sourced from ClinicalTrials.gov (NCT01133405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.