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A Study to Define the ECG Effects of Lixivaptan Compared to Placebo and Moxifloxacin in Healthy Adult Men and Women: A Thorough ECG Study

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ClinicalTrials.gov Identifier: NCT00675701
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : June 21, 2011
Sponsor:
Collaborators:
Cardiokine Biopharma, LLC
Biogen
Information provided by:
CardioKine Inc.

Tracking Information
First Submitted Date  ICMJE May 8, 2008
First Posted Date  ICMJE May 12, 2008
Last Update Posted Date June 21, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
Timed-matched, placebo-corrected, changed from Baseline in QTc [ Time Frame: 7days ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
Time-matched, placebo-corrected, change from Baseline in QTc based on an individual correction method that provides an optimization of interval from onset of QRS complex to end of T wave (QT) correction for heart rate [ Time Frame: 7 days ]
Change History Complete list of historical versions of study NCT00675701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
QTc with Fridericia correction method and the QTc with Bazett correction method; Uncorrected interval from onset of QRS complex to end of T wave (QT) interval; Heart rate;PR interval;QRS interval;Change in electrocardiogram (ECG) morphological patterns; [ Time Frame: : 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 11.5, 14, 16, 18, and 23.5 hours after "time 0" on Day -1 (Baseline) and Day 7. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Define the ECG Effects of Lixivaptan Compared to Placebo and Moxifloxacin in Healthy Adult Men and Women: A Thorough ECG Study
Official Title  ICMJE A Double Blind, Randomized, Repeat-Dose, Parallel Group Study to Define the ECG Effects of Lixivaptan Using a Clinical and a Supratherapeutic Dose, Compared to Placebo and Moxifloxacin (a Positive Control), in Healthy Adult Men and Women: A Thorough ECG Study
Brief Summary This is a Phase 1, double-blind, randomized, repeat-dose, single -dite, 4-arm parallel group study to define the ECG effect of lixivaptan using a therapeutic and supratherapeutic dose compared to placebo and moxifloxacin (a positive control in healthy adult men and women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: placebo
    capsules
  • Drug: lixivaptan
    capsules
  • Drug: moxifloxacin
    tablets
Study Arms  ICMJE
  • Placebo Comparator: A
    Placebo by mouth
    Intervention: Drug: placebo
  • Experimental: B
    lixivaptan
    Intervention: Drug: lixivaptan
  • Active Comparator: C
    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: June 20, 2011)
298
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2008)
300
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy males or females, between 18 and 45 years of age, inclusive
  2. Body mass index (BMI; see 279HAPPENDIX B) within 18 to 32 kg/m2, inclusive
  3. Absence of significant disease as determined by medical history, physical examination, laboratory evaluations, 12-lead ECG, and vital signs (conducted at Screening or on admission to the clinic)
  4. Normal 12-lead ECG with no clinically significant abnormalities of rate, rhythm, or conduction (i.e., normal PR interval of 0.12-0.2 sec, normal QRS duration of 0.06-0.1 sec, and a QTc Bazett <440 ms for males or <470 ms for females)
  5. Clinical laboratory evaluations (including a serum chemistry panel [fasted at least 8 hours], CBC, and UA) within the reference range for the test laboratory. Laboratory findings outside the normal reference range may be repeated once; The subject may be enrolled if laboratory findings outside the normal reference range are deemed not clinically significant by the investigator
  6. Negative test for selected drugs of abuse (280HAPPENDIX A) at Screening and at Check-in
  7. Women must be postmenopausal (more than 12 months since last period, verified by FSH and estradiol measurements); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); or be using an intrauterine device (including hormone-impregnated devices), or double barrier (i.e. diaphragm plus spermicide) non-hormonal contraceptive therapy for the duration of the study; and must have a negative serum pregnancy test at Screening and Check-in
  8. Able to communicate effectively with study personnel
  9. Be adequately informed of the nature and risks of the study and able to comprehend and sign an Informed Consent Form (ICF) prior to any study related procedures.

Exclusion Criteria:

  1. Known hypersensitivity or allergy to lixivaptan (VPA-985), other vasopressin antagonists, moxifloxacin, or any other fluoroquinolones;
  2. Women who are pregnant or breast feeding
  3. A first degree relative with Long QT Syndrome or a family history of unexplained sudden death
  4. Any history, disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, urological, neurological, psychiatric, or central nervous system; or other conditions that might interfere with the absorption, distribution, metabolism, or excretion of study drug, or would place the subject at increased risk
  5. History of unexplained syncope
  6. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy will be allowed)
  7. History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically significant
  8. Screening systolic blood pressure <90 mmHg or >140 mmHg, and/or diastolic blood pressure >90 mmHg
  9. Screening heart rate >90 beats per minute
  10. Positive screen for hepatitis B (HBsAg), hepatitis C (anti-HCV), or HIV (anti-HIV)
  11. Participation in any other investigational study within 30 days prior to Check-in
  12. Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 6 months prior to Check-in
  13. A history of difficulty with donating blood
  14. Donation of ≥ 500 mL blood or blood products within 45 days prior to enrollment
  15. Receipt of blood products within 2 months prior to Check-in
  16. Use of any of the medications in 281HTable 3 within the given timeframe prior to Check-in:
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 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 NCT00675701
Other Study ID Numbers  ICMJE CK-LX1403
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cardiokine, Ink, Cardiokine Biopharma, LLC
Study Sponsor  ICMJE CardioKine Inc.
Collaborators  ICMJE
  • Cardiokine Biopharma, LLC
  • Biogen
Investigators  ICMJE Not Provided
PRS Account CardioKine Inc.
Verification Date November 2008

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