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OpenTrials
Completed

NCT Number: NCT03212638

A Study of Baricitinib in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baricitinib suspension

Drug

Administered orally

Other names: LY3009104

Baricitinib tablet

Drug

Administered orally

Other names: LY3009104

Primary outcomes

  1. 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

    PK: Cmax of baricitinib after a single oral dose

  2. 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

    PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng*hr/mL)

  3. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) 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

    PK: AUC(0-∞) of Baricitinib

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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