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| Sponsor: | CardioKine Inc. |
|---|---|
| Collaborators: |
Cardiokine Biopharma, LLC Biogen Idec |
| Information provided by: | CardioKine Inc. |
| ClinicalTrials.gov Identifier: | NCT00675701 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
A: Placebo Comparator
Placebo by mouth
|
Drug: placebo
capsules
|
|
B: Experimental
lixivaptan
|
Drug: lixivaptan
capsules
|
|
C: Active Comparator
moxifloxacin
|
Drug: moxifloxacin
tablets
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 Therapeutic Uses Pharmacologic Actions |