A Study of Baricitinib in Healthy Japanese Participants

Relative Bioavailability of the Baricitinib (LY3009104) Commercial Tablet Compared to the Phase 2 Tablets and the Effect of Food on the Bioavailability of the Commercial Tablet in Healthy Japanese Subjects

The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Baricitinib

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Hachioji, Tokyo, Japan, 192-0071
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 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: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Overtly healthy Japanese male and female (women not of child-bearing potential or after menopause), as determined by medical history and physical examination
• Have a body mass index (BMI) of 18.5 to 29.9 kilogram per square meter (kg/m^2)
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have an abnormal blood pressure as determined by the investigator
• Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Are women who are pregnant or lactating
• Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing and during the study.
• Have donated blood of more than 400 milliliter (mL) in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males) or 800 mL (females) at screening.
• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
• Are participants who currently smoke more than 10 cigarettes per day (or equivalent in tobacco or nicotine products) or are unwilling to abide by smoking restrictions
• Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
• Have an absolute neutrophil count (ANC) less than 2000 cells/microliter (µL)

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 Test Treatment 1 (T1); Single oral dose of 2 × 4 milligram (mg) baricitinib commercial formulation tablet fasted on Day 1 in one of five periods.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
EXPERIMENTAL: Baricitinib Reference Treatment 1 (R1); Single oral dose of 1 × 8 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
EXPERIMENTAL: Baricitinib Test Treatment 2 (T2); Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet fasted on Day 1 in one of five periods.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
EXPERIMENTAL: Baricitinib Reference Treatment 2 (R2); Single oral dose of 1 × 4 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
EXPERIMENTAL: Baricitinib Test Treatment 2 with Meal (T2F); Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet after food intake on Day 1 in one of five periods.	Drug: Baricitinib; Administered orally; Other Names: LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib	Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib	Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
PK: Maximum Concentration (Cmax) of Baricitinib	Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (ESTIMATE): October 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14612; I4V-MC-JAGO (OTHER: Eli Lilly and Company)