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A Study of LY2484595 on the Electrical Activity of the Heart

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01537887
First received: February 17, 2012
Last updated: June 25, 2012
Last verified: June 2012

February 17, 2012
June 25, 2012
February 2012
June 2012   (final data collection date for primary outcome measure)
Change from baseline in QT interval corrected for heart rate (QTc) for LY2484595 versus placebo [ Time Frame: Baseline, Day 10 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01537887 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: maximum drug concentration (Cmax) of LY2484595 [ Time Frame: Baseline through Day 15 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: area under the concentration curve (AUC) of LY2484595 [ Time Frame: Baseline through Day 15 ] [ Designated as safety issue: No ]
  • Change from baseline to Day 15 in fasting lipid and apolipoprotein profiles [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of LY2484595 on the Electrical Activity of the Heart
A Placebo- and Positive-Controlled Study of the Effect of LY2484595 on QT Interval in Healthy Subjects

The purpose of this study is to evaluate the effect on the electrical activity of the heart as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to 10 days of placebo in relation to a single dose of moxifloxacin. Information about any side effects that occur will also be collected.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: LY2484595
    Administered orally once daily for 10 days.
  • Drug: Placebo
    Administered orally once daily for 10 days.
  • Drug: Moxifloxacin
    Single dose administered orally.
  • Placebo Comparator: Placebo
    Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14 day washout period.
    Intervention: Drug: Placebo
  • Experimental: 1200 mg LY2484595
    Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14 day washout period.
    Intervention: Drug: LY2484595
  • Active Comparator: 400 mg Moxifloxacin
    Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14 day washout period.
    Intervention: Drug: Moxifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males and females
  • Body mass index (BMI) of 18.5 to 29 kg/m^2
  • Reliable and willing to be available for the duration of the study and are willing to follow study procedures
  • Provided written informed consent

Exclusion Criteria:

  • Known allergies to LY2484595 or moxifloxacin
  • Personal or family history of long QT syndrome, heart failure, or low blood potassium (hypokalemia) a family history of sudden death, or unexplained syncope within the last year
  • Positive findings on urinary drug screening
  • Cigarette smokers
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01537887
11947, I1V-MC-EIAK
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2012

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