A Study of Baricitinib in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2017-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Baricitinib in Healthy Japanese Participants

NCT02263911

Healthy Participants

COMPLETED PHASE1

A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants

NCT02340104

Healthy Volunteers

COMPLETED PHASE1

A Study of Baricitinib and Simvastatin in Healthy Participants

NCT01960140

Healthy Volunteers

COMPLETED PHASE1

A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

NCT01870388

Liver Diseases Hepatic Insufficiency

COMPLETED PHASE1

A Study of Baricitinib (LY3009104) in Participants With COVID-19

NCT04421027

COVID-19

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Baricitinib T1 (Part A)

4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)

Group Type EXPERIMENTAL

Baricitinib suspension

Intervention Type DRUG

Administered orally

Baricitinib T2 (Part A)

4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)

Group Type EXPERIMENTAL

Baricitinib suspension

Intervention Type DRUG

Administered orally

Baricitinib R (Part A)

4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)

Group Type EXPERIMENTAL

Baricitinib tablet

Intervention Type DRUG

Administered orally

Baricitinib TF Fasted (Part B)

4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting)

Group Type EXPERIMENTAL

Baricitinib suspension

Intervention Type DRUG

Administered orally

Baricitinib TF Fed (Part B)

4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)

Group Type EXPERIMENTAL

Baricitinib suspension

Intervention Type DRUG

Administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Baricitinib suspension

Administered orally

Intervention Type DRUG

Baricitinib tablet

Administered orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3009104 LY3009104

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes