A Study of Baricitinib in Healthy Participants

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are to determine:

• If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.

• How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.

• The safety and tolerability of baricitinib.

The study has two parts. Individuals will participate in only one part.

Participants will be admitted to the clinical research unit (CRU) and will be discharged from the CRU following the completion of 3 overnight stays.

Each part of this study will last from 8-10 days, not including screening. Follow-up will occur 7 to 14 days after the last dose of baricitinib.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination

• Women not of child-bearing potential

• Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion Criteria:

• Have received live vaccine(s) within 3 months of screening, or intend to during the study

• Have a current or recent history (less than [<] 30 days prior to screening and/or <45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal parasitic, viral (not including rhinopharyngitis), or mycobacterial infection