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Sponsors and Collaborators: |
CardioKine Inc. Cardiokine Biopharma, LLC Biogen Idec |
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Information provided by: | CardioKine Inc. |
ClinicalTrials.gov Identifier: | NCT00675701 |
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 | Intervention | Phase |
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Healthy |
Drug: placebo Drug: lixivaptan Drug: moxifloxacin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 300 |
Study Start Date: | May 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator
Placebo by mouth
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Drug: placebo
capsules
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B: Experimental
lixivaptan
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Drug: lixivaptan
capsules
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C: Active Comparator
moxifloxacin
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Drug: moxifloxacin
tablets
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cardiokine Biopharma, LLC ( Cardiokine, Ink ) |
Study ID Numbers: | CK-LX1403 |
Study First Received: | May 8, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00675701 History of Changes |
Health Authority: | United States: Food and Drug Administration |
To determine whether lixivaptan administration at supratherapeutic or therapeutic doses results in the prolongation
of the QTc interval. |
Anti-Infective Agents Moxifloxacin Healthy |
Anti-Infective Agents Moxifloxacin Therapeutic Uses Pharmacologic Actions |