A Study of Baricitinib in Healthy Participants

Healthy Clinical Trial

Official title:

A Bioequivalence and Food Effect Study in Healthy Subjects Comparing Baricitinib Suspension and Commercial Tablet Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212638
• Other study ID #: 14934
• Secondary ID: I4V-MC-JAGU
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: March 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 1, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Baricitinib suspension
Administered orally
• Baricitinib tablet
Administered orally

Locations

Country	Name	City	State
Singapore	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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose	PK: Cmax of baricitinib after a single oral dose	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
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	PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng*hr/mL)	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
Primary	PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of Baricitinib Following a Single Oral Dose	PK: AUC(0-8) of Baricitinib	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