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Trial record 39 of 62 for:    Baricitinib

A Study of Baricitinib and Simvastatin in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01960140
Recruitment Status : Completed
First Posted : October 10, 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 October 8, 2013
First Posted Date  ICMJE October 10, 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 October 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid [ Time Frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose ]
    The Cmax of simvastatin [a cytochrome P450 (CYP) 3A substrate] and its active acid metabolite (simvastatin acid) is reported.
  • PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid [ Time Frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose ]
    The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
  • Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid [ Time Frame: Predose through 48 hours postdose, Days 1 and 6 ]
  • Pharmacokinetics: Area under the Concentration Curve from Zero to Infinity (AUC [0-∞]) of Simvastatin and Simvastatin Acid [ Time Frame: Predose through 48 hours postdose, Days 1 and 6 ]
Change History Complete list of historical versions of study NCT01960140 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 Simvastatin in Healthy Participants
Official Title  ICMJE Effects of Multiple Baricitinib (LY3009104) Doses on the Pharmacokinetics of a Cytochrome P450 3A Substrate, Simvastatin, in Healthy Subjects
Brief Summary The purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. The study will last approximately 7 days from the first dose to the end of the study (not including screening or follow-up).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Baricitinib
    Administered orally
    Other Name: LY3009104
  • Drug: Simvastatin
    Administered orally
Study Arms  ICMJE
  • Experimental: Simvastatin
    Single oral dose of 40 milligrams (mg) simvastatin on Day 1.
    Intervention: Drug: Simvastatin
  • Experimental: Baricitinib + Simvastatin
    Oral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6.
    Interventions:
    • Drug: Baricitinib
    • Drug: Simvastatin
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: October 8, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 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 squared (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 involving a study drug or off-label use of a drug or device, 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
  • Have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
  • Have known allergies to baricitinib, simvastatin, related compounds, or any components of the baricitinib or simvastatin 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 (including hypothyroidism), hematological, or neurological disorders
  • Have current or recent history of myalgia or muscle weakness
  • 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 (not including rhinopharyngitis), or mycobacterial infection
  • Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
  • Have an absolute neutrophil count (ANC) less than 2 × 10^9/liters (L) [2000 cells/microliter (μL)] at screening or day prior to first dose of study drug. For abnormal values, a single repeat will be allowed
  • 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
  • Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
  • 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 Day 1 until discharge from the Clinical Research Unit (CRU)
  • Have consumed or intend to consume grapefruit or grapefruit-containing products within 14 days prior to the first dose and throughout the study
  • Have donated or lost blood of more than 500 milliliters (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 Period 2
  • 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 NCT01960140
Other Study ID Numbers  ICMJE 14606
I4V-MC-JAGI ( 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