A Study of Baricitinib in Healthy Japanese Participants

NCT02263911 | Completed Phase 1 Results

• 2 other identifiers: 14612I4V-MC-JAGO
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Baricitinib Test Treatment 1 (T1)

EXPERIMENTAL

Single oral dose of 2 × 4 milligram (mg) baricitinib commercial formulation tablet fasted on Day 1 in one of five periods.

Drug: Baricitinib

Baricitinib Reference Treatment 1 (R1)

EXPERIMENTAL

Single oral dose of 1 × 8 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods.

Drug: Baricitinib

Baricitinib Test Treatment 2 (T2)

EXPERIMENTAL

Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet fasted on Day 1 in one of five periods.

Drug: Baricitinib

Baricitinib Reference Treatment 2 (R2)

EXPERIMENTAL

Single oral dose of 1 × 4 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods.

Drug: Baricitinib

Baricitinib Test Treatment 2 with Meal (T2F)

EXPERIMENTAL

Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet after food intake on Day 1 in one of five periods.

Drug: Baricitinib

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

Baricitinib Reference Treatment 1 (R1); Baricitinib Reference Treatment 2 (R2); Baricitinib Test Treatment 1 (T1); Baricitinib Test Treatment 2 (T2); Baricitinib Test Treatment 2 with Meal (T2F)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 192-0071, Japan

Location

MeSH Terms

Interventions

baricitinib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 6, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Locations

JP (1)