Phase 1
Completed N=42
A Safety Study of LY2886721 Multiple Doses in Healthy Subjects
Source: ClinicalTrials.gov NCT01227252 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Clinically Significant Effects — 0; 0; 0; 0 Participants
Summary
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple 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 |
0; 0; 0; 0; 2; 2 | — |
| SECONDARY Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721 |
11.6; 43.0; 80.0 | — |
| SECONDARY Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 |
128; 447; 861 | — |
| SECONDARY Plasma Amyloid Beta (Aβ) 1-40 Concentration |
123; 49; 40; 25 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Concentration of LY2886721 |
0.5; 1.4; 3.8 | — |
| SECONDARY Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration |
-3.9; -11.8; -27.5; -59.1 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy men and non-childbearing potential women
- Body mass index between 18.0-32.0 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01227252). 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.