A Study of Baricitinib in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Baricitinib suspension; Drug: Baricitinib tablet

• Registration Number: NCT03212638
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purposes of this study are to determine:

* If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.

* How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.

* The safety and tolerability of baricitinib.

The study has two parts. Individuals will participate in only one part.

Participants will be admitted to the clinical research unit (CRU) and will be discharged from the CRU following the completion of 3 overnight stays.

Each part of this study will last from 8-10 days, not including screening. Follow-up will occur 7 to 14 days after the last dose of baricitinib.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-27
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Primary Completion: 2017-07-31
• Study Completion: 2017-11-01
• Results First Submitted: 2018-10-26
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-22
• Last Update Submitted: 2019-03-22
• Results First Posted: 2019-03-26
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Are overtly healthy males or females, as determined by medical history and physical examination
• Women not of child-bearing potential
• Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²) inclusive, at screening

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Exclusion Criteria

• Have received live vaccine(s) within 3 months of screening, or intend to during the study
• Have a current or recent history (less than [<] 30 days prior to screening and/or <45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal parasitic, viral (not including rhinopharyngitis), or mycobacterial infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Baricitinib TF Fasted (Part B)	Baricitinib suspension	4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting)
Baricitinib TF Fed (Part B)	Baricitinib suspension	4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
Baricitinib R (Part A)	Baricitinib tablet	4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
Baricitinib T2 (Part A)	Baricitinib suspension	4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
Baricitinib T1 (Part A)	Baricitinib suspension	4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose	Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose	PK: AUC(0-∞) of Baricitinib
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose	Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose	PK: Cmax of baricitinib after a single oral dose
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose	Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose	PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng\*hr/mL)

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇸🇬 Singapore, Singapore