A Study of Baricitinib in Healthy Japanese Participants

NCT ID: NCT02263911

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

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.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Interventions

Baricitinib

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3009104

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

Hachiōji, Tokyo, Japan

Countries

Japan

Other Identifiers

I4V-MC-JAGO

Identifier Type: OTHER

Identifier Source: secondary_id

14612

Identifier Type: -

Identifier Source: org_study_id