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OpenTrials
Completed

NCT Number: NCT02263911

A Study of Baricitinib in Healthy Japanese Participants

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Baricitinib

Drug

Administered orally

Other names: LY3009104

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib

    Time frame: 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

  2. PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib

    Time frame: 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

  3. PK: Maximum Concentration (Cmax) of Baricitinib

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 13, 2014
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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