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A Study to Evaluate the Impact of Activated Charcoal on the Absorption of LY2140023 in Healthy Subjects
The study will evaluate the effect of activated charcoal on absorption of LY2140023. The study involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth 2 times during study (once with activated charcoal, once without activated charcoal). This study will last approximately 16 days, not including screening. Screening is required within 28 days prior to study entry.
Details
| Lead sponsor | Denovo Biopharma LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 27 |
| Start date | 2012-06 |
| Completion | 2012-09 |
Conditions
- Healthy Volunteer Study
Interventions
- LY2140023
- Aqueous activated charcoal
Primary outcomes
- Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2140023 — Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Venous blood samples were collected for pharmacokinetic parameter estimates for LY2140023 alone and in the presence of aqueous activated charcoal. - Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2140023 — Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Venous blood samples were collected for pharmacokinetic parameter estimates for LY2140023 alone and in the presence of aqueous activated charcoal. - Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY404039 (Active Moiety) — Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Venous blood samples were collected for pharmacokinetic parameter estimates for LY404039 alone and in the presence of aqueous activated charcoal. - Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY404039 (Active Moiety) — Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Venous blood samples were collected for pharmacokinetic parameter estimates for LY404039 alone and in the presence of aqueous activated charcoal.
Countries
United Kingdom