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

CardioKine Inc.1 site in 1 country298 target enrollmentMay 2008

ConditionsHealthy

Interventionsplacebo lixivaptan moxifloxacin

Drugsplacebo lixivaptan moxifloxacin

Overview

Phase: Phase 1
Intervention: placebo
Conditions: Healthy
Sponsor: CardioKine Inc.
Enrollment: 298
Locations: 1
Primary Endpoint: Timed-matched, placebo-corrected, changed from Baseline in QTc
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

October 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CardioKine Inc.

Eligibility Criteria

Inclusion Criteria

•Healthy males or females, between 18 and 45 years of age, inclusive
•Body mass index (BMI; see 279HAPPENDIX B) within 18 to 32 kg/m2, inclusive
•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)
•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)
•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
•Negative test for selected drugs of abuse (280HAPPENDIX A) at Screening and at Check-in
•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
•Able to communicate effectively with study personnel
•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

•Known hypersensitivity or allergy to lixivaptan (VPA-985), other vasopressin antagonists, moxifloxacin, or any other fluoroquinolones;
•Women who are pregnant or breast feeding
•A first degree relative with Long QT Syndrome or a family history of unexplained sudden death
•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
•History of unexplained syncope
•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)
•History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically significant
•Screening systolic blood pressure \<90 mmHg or \>140 mmHg, and/or diastolic blood pressure \>90 mmHg
•Screening heart rate \>90 beats per minute
•Positive screen for hepatitis B (HBsAg), hepatitis C (anti-HCV), or HIV (anti-HIV)