Phase 1
Completed N=24
A Study of Baricitinib in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03212638 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose — 49.8; 49.6; 47.8; 47.9 nanograms per milliliter (ng/mL)
Summary
The purposes of this study are to determine:
* If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.
* How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.
* The safety and tolerability of baricitinib.
The study has two parts. Individuals will participate in only one part.
Participants will be admitted to the clinical research unit (CRU) and will be discharged from the CRU following the completion of 3 overnight stays.
Each part of this study will last from 8-10 days, not including screening. Follow-up will occur 7 to 14 days after the last dose of baricitinib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose |
49.8; 49.6; 47.8; 47.9; 32.5 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose |
314; 315; 216; 281; 273 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose |
319; 319; 319; 284; 282 | — |
Eligibility Criteria
Inclusion Criteria
- Are overtly healthy males or females, as determined by medical history and physical examination
- Women not of child-bearing potential
- Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²) inclusive, at screening
Exclusion Criteria
- Have received live vaccine(s) within 3 months of screening, or intend to during the study
- Have a current or recent history (less than [<] 30 days prior to screening and/or <45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
Data sourced from ClinicalTrials.gov (NCT03212638). 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.