A Study of Baricitinib and Probenecid in Healthy Participants

NCT01937026 | Completed Phase 1 Results

• 2 other identifiers: 14604I4V-MC-JAGG
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to assess how the body handles baricitinib when it is given with another drug called probenecid. The study doctor will measure the amount of baricitinib that is absorbed into the blood stream and the time that it takes to remove baricitinib from the body. The safety and tolerability of these drugs will be studied. The study will last about 18 days from the first dose to the end of the study (not including screening).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib

  Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose

• PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib

  Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose

Study Arms (2)

Baricitinib

EXPERIMENTAL

Single oral dose of 4 milligrams (mg) baricitinib on Day 1

Drug: Baricitinib

Baricitinib + Probenecid

EXPERIMENTAL

Oral doses of 1000 mg probenecid once daily on Days 3 through 7, with a single oral dose of 4 mg baricitinib co-administered on Day 5

Drug: Baricitinib; Drug: Probenecid

Interventions

Baricitinib DRUG

Administered orally

Baricitinib; Baricitinib + Probenecid

Probenecid DRUG

Administered orally

Baricitinib + Probenecid

Eligibility Criteria

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

You may qualify if:

• Male participants: agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
• Female participants: women not of childbearing potential due to surgical sterilization confirmed by medical history or menopause
• Have a body mass index of 18.0 to 29.0 kilograms per meter square (kg/m\^2), inclusive
• Have clinical laboratory test results within the normal reference range
• Have normal renal function
• Have normal blood pressure and pulse rate

You may not qualify if:

• Are currently enrolled in a clinical trial or are concurrently enrolled in any other type of medical research
• Have completed or discontinued within the last 90 days from a clinical trial involving a study drug
• Are participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
• Have known allergies to baricitinib, probenecid, related compounds, or any components of the baricitinib or probenecid formulations, or history of significant atopy
• Have an abnormality in the 12-lead electrocardiogram (ECG)
• Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs;
• Have a history of or current gout or gouty arthritis
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral, or mycobacterial infection
• Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Show evidence of hepatitis C infection and/or positive hepatitis C antibody
• Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen
• Are women who are lactating
• Intend to use over-the-counter or prescription medication (including salicylate drugs) and/or herbal supplements within 14 days prior to dosing and during the study or intended use of vitamin supplements from first dose of study drug until discharge from the Clinical Research Unit (CRU)

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

baricitinib; Probenecid

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

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

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: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 9, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 6, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Locations

GB (1)