A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02758613

I4V-GH-JAGR (Other Identifier)

14778

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 4 patient groups, including a placebo group

2 milligram (mg) Baricitinib

Experimental group

Description:

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

Treatment:

Drug: Baricitinib

4mg Baricitinib

Experimental group

Description:

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

Treatment:

Drug: Baricitinib

10mg Baricitinib

Experimental group

Description:

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

Treatment:

Drug: Baricitinib

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo