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A Study of Baricitinib in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03212638
Recruitment Status : Completed
First Posted : July 11, 2017
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Baricitinib suspension Drug: Baricitinib tablet Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Bioequivalence and Food Effect Study in Healthy Subjects Comparing Baricitinib Suspension and Commercial Tablet Formulations
Actual Study Start Date : June 27, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Baricitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Baricitinib T1 (Part A)
4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
 Drug: Baricitinib suspension
Administered orally
Other Name: LY3009104
Experimental: Baricitinib T2 (Part A)
4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
 Drug: Baricitinib suspension
Administered orally
Other Name: LY3009104
Experimental: Baricitinib R (Part A)
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
 Drug: Baricitinib tablet
Administered orally
Other Name: LY3009104
Experimental: Baricitinib TF Fasted (Part B)
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting)
 Drug: Baricitinib suspension
Administered orally
Other Name: LY3009104
Experimental: Baricitinib TF Fed (Part B)
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
 Drug: Baricitinib suspension
Administered orally
Other Name: LY3009104


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose [ Time Frame: 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

  2. 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 [ Time Frame: 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)

  3. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212638


Locations
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Singapore
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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 Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] September 28, 2016
Statistical Analysis Plan  [PDF] July 5, 2017

More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03212638    
Other Study ID Numbers: 14934
I4V-MC-JAGU ( Other Identifier: Eli Lilly and Company )
First Posted: July 11, 2017    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No