A Study of Baricitinib in Healthy Participants

NCT03212638 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 14934I4V-MC-JAGU
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose

  PK: AUC(0-∞) 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

Study Arms (5)

Baricitinib T1 (Part A)

EXPERIMENTAL

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

Drug: Baricitinib suspension

Baricitinib T2 (Part A)

EXPERIMENTAL

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

Drug: Baricitinib suspension

Baricitinib R (Part A)

EXPERIMENTAL

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

Drug: Baricitinib tablet

Baricitinib TF Fasted (Part B)

EXPERIMENTAL

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

Drug: Baricitinib suspension

Baricitinib TF Fed (Part B)

EXPERIMENTAL

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

Drug: Baricitinib suspension

Interventions

Baricitinib suspension DRUG

Administered orally

Also known as: LY3009104

Baricitinib T1 (Part A); Baricitinib T2 (Part A); Baricitinib TF Fasted (Part B); Baricitinib TF Fed (Part B)

Baricitinib tablet DRUG

Administered orally

Also known as: LY3009104

Baricitinib R (Part A)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, Singapore

Location

MeSH Terms

Interventions

baricitinib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

Clinicaltrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: June 27, 2017
• Primary Completion: July 31, 2017
• Study Completion: November 1, 2017
• Last Updated: March 26, 2019
• Results First Posted: March 26, 2019

Record last verified: 2019-03

Locations

SG (1)