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Phase 1 Completed N=33 Randomized Double-blind Basic Science

A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

Healthy
Source: ClinicalTrials.gov NCT02758613 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Number of Participants With One or More Clinically Significant Event(s) — 4; 0; 2; 4 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With One or More Clinically Significant Event(s)
4; 0; 2; 4
SECONDARY
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib
24.3; 47.8; 147; 28.0; 48.0; 136
SECONDARY
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib
139; 270; 777; 145; 265; 771

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02758613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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