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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03212638 |
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Date of registration:
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07/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Baricitinib in Healthy Participants
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Scientific title:
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A Bioequivalence and Food Effect Study in Healthy Subjects Comparing Baricitinib Suspension and Commercial Tablet Formulations |
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Date of first enrolment:
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June 27, 2017 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03212638 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Baricitinib suspension
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Drug: Baricitinib tablet
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Primary Outcome(s)
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Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose
[Time Frame: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose]
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PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of Baricitinib Following a Single Oral Dose
[Time Frame: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose]
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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
[Time Frame: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose]
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Secondary ID(s)
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I4V-MC-JAGU
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14934
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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