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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: LY2484595
Drug: Placebo
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Placebo- and Positive-Controlled Study of the Effect of LY2484595 on QT Interval in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
Administered orally once daily for 10 days.
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.
Drug: LY2484595
Administered orally once daily for 10 days.
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.
Drug: Moxifloxacin
Single dose administered orally.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537887

Locations
United States, Florida
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.
Daytona Beach, Florida, United States, 32117
United States, Indiana
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.
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01537887     History of Changes
Other Study ID Numbers: 11947, I1V-MC-EIAK
Study First Received: February 17, 2012
Last Updated: June 25, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014