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A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

NCT ID: NCT02758613

Last Updated: 2017-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2 milligram (mg) Baricitinib

2mg Baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Administered orally.

4mg Baricitinib

4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Administered orally.

10mg Baricitinib

10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Administered orally.

Placebo

Placebo matching Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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Baricitinib

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY3009104

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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China

Other Identifiers

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I4V-GH-JAGR

Identifier Type: OTHER

Identifier Source: secondary_id

14778

Identifier Type: -

Identifier Source: org_study_id