A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

NCT02758613 | Completed Phase 1 Results

• 2 other identifiers: 14778I4V-GH-JAGR
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Clinically Significant Event(s)

  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.

  Baseline through Study Completion (up to Day 20)

Secondary Outcomes (2)

• Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib

  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

• Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib

  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

Study Arms (4)

2 milligram (mg) Baricitinib

EXPERIMENTAL

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

Drug: Baricitinib

4mg Baricitinib

EXPERIMENTAL

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

Drug: Baricitinib

10mg Baricitinib

EXPERIMENTAL

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

Drug: Baricitinib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Baricitinib DRUG

Administered orally.

Also known as: LY3009104

10mg Baricitinib; 2 milligram (mg) Baricitinib; 4mg Baricitinib

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 100034, China

Location

MeSH Terms

Interventions

baricitinib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5079

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 2, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 7, 2017
• Results First Posted: December 7, 2017

Record last verified: 2017-07

Locations

CN (1)