A Study of Baricitinib in Healthy Participants

A Bioequivalence and Food Effect Study in Healthy Subjects Comparing Baricitinib Suspension and Commercial Tablet Formulations

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Baricitinib suspension; Drug: Baricitinib tablet

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Baricitinib T1 (Part A); 4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)	Drug: Baricitinib suspension; Administered orally; Other Names: LY3009104
EXPERIMENTAL: Baricitinib T2 (Part A); 4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)	Drug: Baricitinib suspension; Administered orally; Other Names: LY3009104
EXPERIMENTAL: Baricitinib R (Part A); 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)	Drug: Baricitinib tablet; Administered orally; Other Names: LY3009104
EXPERIMENTAL: Baricitinib TF Fasted (Part B); 4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting)	Drug: Baricitinib suspension; Administered orally; Other Names: LY3009104
EXPERIMENTAL: Baricitinib TF Fed (Part B); 4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)	Drug: Baricitinib suspension; Administered orally; Other Names: LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose	PK: Cmax of baricitinib after a single oral dose	Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose	PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng*hr/mL)	Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose	PK: AUC(0-∞) of Baricitinib	Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 27, 2017
• Primary Completion (ACTUAL): July 31, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 14934; I4V-MC-JAGU (OTHER: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No