A Study of Baricitinib in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Baricitinib suspension; Drug: Baricitinib tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03212638

14934

I4V-MC-JAGU (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 5 patient groups

Baricitinib T1 (Part A)

Experimental group

Description:

4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)

Treatment:

Drug: Baricitinib suspension

Baricitinib T2 (Part A)

Experimental group

Description:

4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)

Treatment:

Drug: Baricitinib suspension

Baricitinib R (Part A)

Experimental group

Description:

4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)

Treatment:

Drug: Baricitinib tablet

Baricitinib TF Fasted (Part B)

Experimental group

Description:

4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting)

Treatment:

Drug: Baricitinib suspension

Baricitinib TF Fed (Part B)

Experimental group

Description:

4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)

Treatment:

Drug: Baricitinib suspension