NCT01398475

A Relative Bioavailability and Food Effect Study of New Formulations

Relative Bioavailability of the LY3009104 Free Base Test Formulation Compared to the Reference Phosphate Salt Formulation and the Effect of Food on the Bioavailability of the Test Formulation in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to assess the effect of 3 formulations on the relative bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4 separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK) samples will be collected during each treatment period. Approximately 5 to 7 days of washout period between each treatment and a follow-up visit will occur approximately 5 to 7 days after the last dose of study drug.

Conditions

• Chronic Inflammatory Disorder
• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	LY3009104	Administered orally

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-07-20
• Last updated: 2017-04-21
• Results posted: 2017-04-21

Locations

1 site across 1 country: Singapore