A Study of Baricitinib (LY3009104) in Healthy Chinese Participants
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|ClinicalTrials.gov Identifier: NCT02758613|
Recruitment Status : Completed
First Posted : May 2, 2016
Results First Posted : December 7, 2017
Last Update Posted : December 7, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Baricitinib Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|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|
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).
Other Name: LY3009104
Experimental: 4mg Baricitinib
4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
Other Name: LY3009104
Experimental: 10mg Baricitinib
10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
Other Name: LY3009104
Placebo Comparator: Placebo
Placebo matching Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
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
|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|
|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|
|Responsible Party:||Eli Lilly and Company|
|Other Study ID Numbers:||
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|