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A Study of Baricitinib (LY3009104) in Healthy Chinese 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: NCT02758613
Recruitment Status : Completed
First Posted : May 2, 2016
Results First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to investigate the safety and tolerability of the study drug known as baricitinib in healthy Chinese participants. The study will measure how the body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Healthy Chinese Subjects
Study Start Date : May 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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: 2 milligram (mg) Baricitinib
2mg Baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104
Experimental: 4mg Baricitinib
4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104
Experimental: 10mg Baricitinib
10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104
Placebo Comparator: Placebo
Placebo matching Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
 Drug: Placebo
Administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With One or More Clinically Significant Event(s) [ Time Frame: Baseline through Study Completion (up to Day 20) ]
    Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.


Secondary Outcome Measures :
  1. Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib [ Time Frame: Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose ]
    Maximum observed drug concentration for single dose and Cmax as steady date for multiple dosing.

  2. Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib [ Time Frame: Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose ]
    Area under the concentration versus time curve from zero to infinity (AUC0-inf) during single dose and area under the concentration versus time curve (AUCtau,ss) during multiple dose of baricitinib at steady state.


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:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy Chinese males agreed to use methods of birth control or are postmenopausal Chinese females, as determined by medical history and physical examination
  • Have a body mass index of 19.0 to 24.0 kilograms per meter squared (kg/m²), inclusive, at screening.
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
  • Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

Exclusion Criteria:

  • Have a history of adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications.
  • Have an abnormality in the 12-lead electrocardiogram (ECG).
  • 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.
  • Have a history of stomach or intestinal surgery.
  • Current or recent history (<30 days prior to screening of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection.
  • Have an absolute neutrophil count (ANC) less than 2000 cell/microliter (μL) (2 x 109/liter [L]).
  • Have current herpes zoster or simplex within 90 days prior to the first dose,
  • Have evidence of active or latent tuberculosis (TB)
  • Have used or intend to use over-the-counter, prescription medication, or Chinese herbal preparation within 14 days prior to dosing and during the study.
  • Have consumed grapefruit, grapefruit juice, or grapefruit products within 7 days prior to the first dose or are unwilling to abide by the grapefruit restrictions during the study.
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): NCT02758613


Locations
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China
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.
Beijing, China, 100034
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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02758613    
Other Study ID Numbers: 14778
I4V-GH-JAGR ( Other Identifier: Eli Lilly and Company )
First Posted: May 2, 2016    Key Record Dates
Results First Posted: December 7, 2017
Last Update Posted: December 7, 2017
Last Verified: July 2017