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A Comparison Study of Capsule and Orally Disintegrating Tablet and to Determine the Effect of Food and Water on the Pharmacokinetics of LY2886721 in Healthy Subjects
The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks. This study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 26 |
| Start date | 2013-02 |
| Completion | 2013-05 |
Conditions
- Healthy Volunteers
Interventions
- LY2886721 in a Capsule
- LY2886721 in an orally disintegrating tablet (ODT)
Primary outcomes
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 — Baseline through 96 hours post-dose
- Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721 — Baseline through 96 hours post-dose
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 — Baseline through 96 hours post-dose
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721 — Baseline through 96 hours post-dose
Countries
United States