Working… Menu

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

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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: placebo Drug: lixivaptan Drug: moxifloxacin Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: A
Placebo by mouth
Drug: placebo

Experimental: B
Drug: lixivaptan

Active Comparator: C
Drug: moxifloxacin

Primary Outcome Measures :
  1. Timed-matched, placebo-corrected, changed from Baseline in QTc [ Time Frame: 7days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00675701

Layout table for location information
United States, Texas
Research Site 1
Austin, Texas, United States, 78744
Sponsors and Collaborators
CardioKine Inc.
Cardiokine Biopharma, LLC

Layout table for additonal information
Responsible Party: Cardiokine, Ink, Cardiokine Biopharma, LLC Identifier: NCT00675701     History of Changes
Other Study ID Numbers: CK-LX1403
First Posted: May 12, 2008    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: November 2008
Keywords provided by CardioKine Inc.:
To determine whether lixivaptan administration at supratherapeutic or therapeutic doses results in the prolongation of the QTc interval.
Additional relevant MeSH terms:
Layout table for MeSH terms
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs