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Relative Bioavailability of the Baricitinib (LY3009104) Commercial Tablet Compared to the Phase 2 Tablets and the Effect of Food on the Bioavailability of the Commercial Tablet in Healthy Japanese Subjects

Relative Bioavailability of the Baricitinib (LY3009104) Commercial Tablet Compared to the Phase 2 Tablets and the Effect of Food on the Bioavailability of the Commercial Tablet in Healthy Japanese Subjects

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222636
Enrollment
Unknown
Registered
2014-10-17
Start date
2014-10-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Overtly healthy Japanese male and female (women not of child-bearing potential or after menopause), as determined by medical history and physical examination - Have a body mass index (BMI) of 18.5 to 29.9 kg/m2 - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

Exclusion criteria: - Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study - Have an abnormal blood pressure as determined by the investigator - 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 - Are women who are pregnant or lactating - Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing and during the study. - Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males) or 800 mL (females) at screening. - Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions - Are participants who currently smoke more than 10 cigarettes per day (or equivalent in tobacco or nicotine products) or are unwilling to abide by smoking restrictions - Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection - Have an absolute neutrophil count (ANC) less than 2000 cells/microL

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026