pomaglumetad methionil (DB103) - Denovo
A study of LY2140023 in healthy participants (clinicaltrials.gov) - Jul 26, 2012 - P1, N=18; Not yet recruiting -> Recruiting 
Enrollment status • Schizophrenia
http://clinicaltrials.gov/ct2/show/NCT01637142
 
Jul 26, 2012
 
This study is currently recruiting participants. Verified July 2012 by Eli Lilly and Company  First Received on June 28, 2012.   Last Updated on July 26, 2012   History of Changes  Sponsor:   Eli Lilly and Company Information provided by (Responsible Party):  Eli Lilly and Company ClinicalTrials.gov Identifier:  NCT01637142 Purpose The purpose of this study is to assess the extent and rate of absorption of LY2140023 in healthy participants. The study has two periods. In Period 1, participants will receive a single oral dose of 80 mg LY2140023 followed by a 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nCi [14C]-LY2140023. In Period 2, participants will receive an oral dose of 80 mg LY2140023 followed by a 2-hour IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi [14C]-LY404039. There will be at least a 3-day washout between doses. Condition   Healthy Participants Intervention   Drug: LY2140023 Drug: 14C-LY2140023 Drug: 14C-LY404039  Phase  Phase 1 Study Type:  Interventional Study Design: Allocation: Non-Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science Official Title: An Absolute Bioavailability Study of LY2140023 and LY404039 in Healthy Subjects Using the Intravenous Tracer Method Further study details as provided by Eli Lilly and Company: Primary Outcome Measures: Pharmacokinetics: Area under the concentration versus time curve from time zero to infinity (AUC[0-inf]) of LY2140023 and LY404039 [ Time Frame: Up to 24 hours after administration of study drug ] [ Designated as safety issue: No ] Estimated Enrollment: 18 Study Start Date: July 2012 Estimated Study Completion Date: July 2012 Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure) (IR5)