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Trial record 51 of 62 for:    Baricitinib

A Study of LY3009104 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: NCT01536951
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 16, 2012
First Posted Date  ICMJE February 22, 2012
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 February 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval [ Time Frame: Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose ]
    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period [-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104 [ Time Frame: Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug ]
  • Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104 [ Time Frame: Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug ]
  • Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) [ Time Frame: Baseline through study completion and 30-day follow-up ]
    The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2012)
  • Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Up to 48 hours after administration of study drug ]
  • Part A. Pharmacokinetics: maximum concentration (Cmax) of LY3009104 [ Time Frame: Up to 48 hours after administration of study drug ]
  • Part A. Pharmacokinetics: area under the concentration curve (AUC) of LY3009104 [ Time Frame: Up to 48 hours after administration of study drug ]
  • Part B. Change from baseline through 24 hours post-dose in QTcF interval between LY3009104 and placebo [ Time Frame: Baseline, 24 hours post-dose ]
Change History Complete list of historical versions of study NCT01536951 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 LY3009104 in Healthy Participants
Official Title  ICMJE A Placebo-Controlled, Single Dose, Dose Escalation (Part A) and a Placebo- and Positive-Controlled Study of the Effect on the Electrocardiographic QT Interval of a Single Dose (Part B) of LY3009104 in Healthy Subjects
Brief Summary

This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females.

Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to participants. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected.

Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: LY3009104
    administered orally
    Other Name: Baricitinib
  • Drug: Placebo
    Administered orally
  • Drug: moxifloxacin
    Administered orally
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo matching LY3009104 tablets in size and appearance will be administered orally in 1 out of 3 study periods in Part A and Part B.
    Intervention: Drug: Placebo
  • Experimental: LY3009104

    Part A. Single escalating dose of up to 40 milligrams (mg) of LY3009104 administered orally in 2 out of 3 study periods separated by at least a 3 day wash-out period between each dose.

    Part B. Single dose of LY3009104 determined in Part A administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.

    Intervention: Drug: LY3009104
  • Active Comparator: 400 mg moxifloxacin
    Part B. 400 mg moxifloxacin will be administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.
    Intervention: Drug: moxifloxacin
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: March 10, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2012)
69
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are overtly healthy males or females as determined by medical history and physical examination. Are drug free, disease free, and no cardiac abnormalities.
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
  • Have a clinically normal screening ECG with a measurable QT interval as judged by the investigator, and which in Part B allows accurate measurements of QT interval.

Exclusion Criteria:

  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
  • Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the corrected QT (QTc) analysis or have QTc greater than 450 milliseconds (msec).
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
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 States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01536951
Other Study ID Numbers  ICMJE 14448
I4V-MC-JADO ( 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 Incyte Corporation
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