Phase 1
Completed N=30
A Study of LY2886721 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01534273 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Number of Participants With Clinically Significant Effects — 3; 1; 3; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Effects |
3; 1; 3; 2; 1 | — |
| SECONDARY Pharmacokinetics: Plasma Maximum Observed Concentration (Cmax) of LY2886721 |
182; 419 | — |
| SECONDARY Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of LY2886721 |
2110; 4660 | — |
| SECONDARY Pharmacokinetics: Plasma Maximum Observed Concentration at Steady State (Cmax,ss) of LY2886721 |
112; 230 | — |
| SECONDARY Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 |
1100; 2400 | — |
| SECONDARY Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at Day 15 |
-0.97; -74.46 | — |
| SECONDARY Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at 24 Hours Post-dose |
-11.59; -64.75; -72.05 | — |
Eligibility Criteria
Inclusion Criteria
- 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
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 (NCT01534273). 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.