Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 62 for:    Baricitinib

A Study of Baricitinib and Probenecid in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01937026
Recruitment Status : Completed
First Posted : September 9, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 3, 2013
First Posted Date  ICMJE September 9, 2013
Results First Submitted Date  ICMJE March 10, 2017
Results First Posted Date  ICMJE April 21, 2017
Last Update Posted Date June 6, 2017
Study Start Date  ICMJE September 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib [ Time Frame: 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 [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2013)
  • Pharmacokinetics: Maximum Concentration (Cmax) of Baricitinib [ Time Frame: Predose of baricitinib up to 72 hours post dose, Days 1 and 5 ]
  • Pharmacokinetics: Area Under the Concentration Curve time 0 to infinity (AUC [0-∞]) of Baricitinib [ Time Frame: Predose of baricitinib up to 72 hours post dose, Days 1 and 5 ]
Change History Complete list of historical versions of study NCT01937026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Baricitinib and Probenecid in Healthy Participants
Official Title  ICMJE A Study to Investigate the Potential Impact of Organic Anion Transporter 3 Inhibition by Probenecid on the Pharmacokinetics of Baricitinib (LY3009104) in Healthy Subjects
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Baricitinib
    Administered orally
  • Drug: Probenecid
    Administered orally
Study Arms  ICMJE
  • Experimental: Baricitinib
    Single oral dose of 4 milligrams (mg) baricitinib on Day 1
    Intervention: Drug: Baricitinib
  • Experimental: Baricitinib + Probenecid
    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
    Interventions:
    • Drug: Baricitinib
    • Drug: Probenecid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2013)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Have consumed or intend to consume grapefruit or grapefruit-containing products within 7 days prior to the first dose and throughout the study
  • Have used or intend to use any drugs or substances that are known to be substrates, inhibitors, or inducers of organic anion transporter (OAT)3 or cytochrome P450 (CYP) 3A4
  • Have donated or lost blood of more than 500 milliliter (mL) within the last 3 months
  • Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to the first dose until discharge from the CRU at the end of study
  • History of, in the opinion of the investigator, excessive methylxanthine use within the previous 6 months, such as greater than (>) 6 cups of coffee (or equivalent) per day
  • Currently smoke more than 10 cigarettes per day
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01937026
Other Study ID Numbers  ICMJE 14604
I4V-MC-JAGG ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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
PRS Account Eli Lilly and Company
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP