Phase 1
Completed N=40
A Safety Study of LY2886721 Single Doses in Healthy Subjects
Source: ClinicalTrials.gov NCT01133405 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Clinically Significant Effects (Adverse Events) — 0; 0; 0; 0 Participants
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.
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 | — |
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. Informational only — not medical advice.