A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants

An Absolute Bioavailability Study of Baricitinib in Healthy Subjects Using the Intravenous Tracer Method

The purpose of this study is to compare how much baricitinib (study drug) gets into the blood stream when it is given as a single dose (in tablet form) and as an intravenous infusion (injection given directly into a vein via a small needle). Each participant in the study will make four visits to the investigator site over the course of about 6 weeks.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Baricitinib; Drug: [^13C4D3^15N]-baricitinib

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Yorkshire
    • Leeds, Yorkshire, United Kingdom, LS2 9LH
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination
• Male participants: agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
• Female participants: women not of childbearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or menopause. Menopausal women are women with spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (eg, oral contraceptives, hormones, gonadotropin releasing hormone, anti estrogens, selective estrogen receptor modulators, or chemotherapy). Menopausal status should be confirmed by a follicle stimulating hormone (FSH) level greater than 40 international units per liter (IU/L) at screening. Female participants who have been sterilized by tubal ligation will be required to use contraception from the time of screening until 28 days after the last dose of study drug
• Have a body mass index of 18.0 to 32.0 kilogram per meter square (kg/m^2), inclusive, at screening
• Have venous access sufficient to allow for blood sampling and (IV) administration of study drug

Exclusion Criteria:

• Are participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
• Have known allergies to baricitinib, related compounds, or any components of the formulation, or history of significant atopy
• 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 a history or presence 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
• Have a current or recent history (<30 days prior to screening and/or <45 days prior to day before study drug administration) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
• Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to dosing
• Have an absolute neutrophil count (ANC) less than 2 × 109/liter (L) (2000 cells per microliter [cells/μL]) at screening or day before study drug administration. For abnormal values, a single repeat will be allowed
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Show evidence of hepatitis C infection and/or positive hepatitis C antibody
• Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen
• Are women who are pregnant or lactating
• Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
• Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study (with the exception of occasional paracetamol, which will be permitted at the discretion of the investigator), or intended use of vitamin supplements from study drug administration until discharge from the Clinical Research Unit (CRU)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baricitinib; Single oral dose of baricitinib and single intravenous (IV) infusion of [^13C4D3^15N]-baricitinib over 1.5 hours.	Drug: Baricitinib; 4 milligrams (mg) administered orally; Other Names: LY3009104; Drug: [^13C4D3^15N]-baricitinib; 4 micrograms (μg) administered intravenously (IV); Other Names: [^13C4D3^15N]-LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose	AUC[0-∞] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng*h/mL).	Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 16, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14610; I4V-MC-JAGM (Other Identifier: Eli Lilly and Company)