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Trial record 26 of 80471 for:    subjects

A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02222324
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE August 19, 2014
First Posted Date  ICMJE August 21, 2014
Last Update Posted Date November 3, 2015
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
Change from baseline in QTcF obtained from ECGs extracted from the Holter recordings [ Time Frame: Up to 24 hours postdose during each treatment period ]
Holter recordings are taken from a portable device for continuously monitoring various electrical activity of the cardiovascular system for at least 24 hours. Baseline is defined as the mean of predose QTcF values obtained from ECGs extracted from Holter recordings before dosing during each treatment period.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02222324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
  • Change from baseline in ECG recordings: PR interval [ Time Frame: Predose and then up to 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Change from baseline in ECG recordings: QRS interval [ Time Frame: Predose and then up to 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Change from baseline in ECG recordings: HR [ Time Frame: Predose and then up 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Change from baseline in ECG recordings: RR interval [ Time Frame: Predose and then at up to 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Change from baseline in ECG recordings: T wave morphology [ Time Frame: Predose and then at up to 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Pharmacokinetics of E2609: Cmax [ Time Frame: Up to 84 Days ]
    Maximum drug concentration
  • Pharmacokinetics of E2609: tmax [ Time Frame: Up to 84 Days ]
    Ttime to reach maximum (peak) concentration following drug administration
  • Pharmacokinetics of E2609: AUC(0-t) [ Time Frame: Up to 84 Days ]
    Area under the concentration x time curve from time = 0 to time of last measurable concentration
  • Pharmacokinetics of E2609: AUC(0-72h) [ Time Frame: Up to 84 Days ]
    Area under the concentration x time curve from time = 0 to 72 hours postdose
  • Pharmacokinetics of E2609: AUC(0-inf) [ Time Frame: Up to 84 Days ]
    Area under the concentration x time curve from time = 0 to infinity
  • Pharmacokinetics of E2609: t1/2 [ Time Frame: Up to 84 Days ]
    Terminal elimination half-life
  • Pharmacokinetics of E2609: CL/F [ Time Frame: Up to 84 Days ]
    Apparent total clearance following extravascular administration
  • Pharmacokinetics of E2609: Vz/F [ Time Frame: Up to 84 Days ]
    Apparent volume of distribution following extravascular administration
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • Change from baseline in ECG recordings: PR interval [ Time Frame: Predose and then up to 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Change from baseline in ECG recordings: QRS interval [ Time Frame: Predose and then up to 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Change from baseline in ECG recordings: HR [ Time Frame: Predose and then up 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Change from baseline in ECG recordings: RR interval [ Time Frame: Predose and then at up to 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Change from baseline in ECG recordings: T wave morphology [ Time Frame: Predose and then at up to 24 hours postdose in each treatment period ]
    Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
  • Pharmacokinetics of E2609: Cmax [ Time Frame: Up to 84 Days ]
    Maximum drug concentration
  • Pharmacokinetics of E2609: tmax [ Time Frame: Up to 84 Days ]
    Time to reach maximum (peak) concentration following drug administration
  • Pharmacokinetics of E2609: AUC(0-t) [ Time Frame: Up to 84 Days ]
    Area under the concentration x time curve from time = 0 to time of last measurable concentration
  • Pharmacokinetics of E2609: AUC(0-72h) [ Time Frame: Up to 84 Days ]
    Area under the concentration x time curve from time = 0 to 72 hours postdose
  • Pharmacokinetics of E2609: AUC(0-inf) [ Time Frame: Up to 84 Days ]
    Area under the concentration x time curve from time = 0 to infinity
  • Pharmacokinetics of E2609: t1/2 [ Time Frame: Up to 84 Days ]
    Terminal elimination half-life
  • Pharmacokinetics of E2609: CL/F [ Time Frame: Up to 84 Days ]
    Apparent total clearance following extravascular administration
  • Pharmacokinetics of E2609: Vz/F [ Time Frame: Up to 84 Days ]
    Apparent volume of distribution following extravascular administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
Official Title  ICMJE A Randomized, Double-Blind, Placebo and Active-Controlled, Single-Dose, 4-Treatment Crossover Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
Brief Summary This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each treatment sequence will comprise all 4 treatments.
Detailed Description The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will have 2 periods: Screening (up to 27 days) and Baseline Period 1 (1 day). Eligibility will be determined during the Screening Period. The Randomization Phase will consist of 8 periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, Treatment Period 3, Baseline Period 4, Treatment Period 4, and a Follow-Up Period. Each Baseline Period will last 1 day, followed by the corresponding treatment period. On the first day of each treatment period, subjects will receive a single dose of the assigned study drug. During each treatment period, subjects will be required to stay in the clinical unit from the baseline period to 24 hours postdose. Subjects will then be released from the clinic and will undergo a washout interval of at least 13 days, during which time they will return for additional PK sampling.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: Placebo
    8 placebo tablets matching E2609
  • Drug: E2609
    E2609 will be administered as 8 tablets
  • Drug: Moxifloxacin
    Administered as 1 tablet with 7 tablets of placebo matching E2609
Study Arms  ICMJE
  • Placebo Comparator: Treatment A
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Treatment B
    E2609 Low dose
    Intervention: Drug: E2609
  • Experimental: Treatment C
    E2609 High dose
    Intervention: Drug: E2609
  • Active Comparator: Treatment D
    Moxifloxacin
    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: August 19, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Subjects must meet all of the following criteria to be included in this study:

  1. Healthy, non-smoking, male or female subjects ages greater than or equal to 18 years to less than or equal to 55 years old at the time of informed consent
  2. Body mass index (BMI) of greater than or equal to 18 to less than or equal to 30 kg/m2 at Screening
  3. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative betahuman chorionic gonadotropin [B-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  4. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], or have a vasectomized partner with confirmed azoospermia, but not oral contraceptive or contraceptive implant) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Hormonal contraceptives (oral or implant) are not permitted forms of contraception in this study. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).
  5. Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

  1. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before dosing
  2. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism)
  3. Any history of gastrointestinal surgery that may affect PK profiles of study drugs (eg, hepatectomy, nephrectomy, or digestive organ resection)
  4. Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that requires medical treatment at Screening or Baseline Periods
  5. History of any medical condition which, in the opinion of the investigator, may interfere with study procedures or compromise subject safety
  6. A prolonged QT/corrected QT interval (QTc) interval (QTc greater than 450 msec) as demonstrated by the mean of triplicate ECGs at Screening or Baseline Periods
  7. History of risk factors for torsade de pointes or the use of concomitant medications that prolonged the QT/QTc interval
  8. Persistent systolic blood pressure (BP) greater than 130 mmHg or less than 90 mmHg and diastolic BP greater than 85 mmHg or less than 60 mmHg at Screening or Baseline Periods
  9. Heart rate less than 50 or greater than 100 beats/minute at Screening or Baseline Periods
  10. History of prolonged QT/QTc interval
  11. Left bundle branch block at Screening or Baseline Periods
  12. History of myocardial infarction or active ischemic heart disease
  13. History of clinically significant arrhythmia or uncontrolled arrhythmia
  14. Any other clinically significant ECG abnormalities at Screening or Baseline Periods
  15. Known history of clinically significant drug allergy (including to study drugs or any of their excipients) at Screening or Baseline
  16. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline Periods
  17. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
  18. History of drug or alcohol dependency or abuse within the 2 years before Screening, or who have a positive urine drug or alcohol test at Screening or Baseline Periods
  19. Use of recreational drugs
  20. Intake of caffeinated beverages or food within 72 hours before dosing
  21. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (eg, alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [eg, kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard], and charbroiled meats) within 1 week before dosing
  22. Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
  23. Use of prescription drugs within 4 weeks before dosing
  24. Intake of over-the-counter (OTC) medications within 2 weeks before dosing
  25. Smoking or use of tobacco or nicotine-containing products within 4 weeks before dosing
  26. Engagement in strenuous exercise within 2 weeks before dosing (eg, marathon runners, weight lifters)
  27. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days preceding informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT02222324
Other Study ID Numbers  ICMJE E2609-A001-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date November 2015

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