CAEB071 Thorough QTc Study in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01594255
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Healthy male and female subjects age 18 to 50 years (including both) of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
Exclusion Criteria
- Smokers and tobacco product users (in the previous 3 months).
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- A marked baseline prolongation of QT/QTcF interval
- Presence of clinically significant illness
- Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AEB071 900 mg sotrastaurin - Placebo to AEB071 placebo to sotrastaurin - Moxifloxacin Avelox - AEB071 300 mg sotrastaurin -
- Primary Outcome Measures
Name Time Method Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo. 24 hours
- Secondary Outcome Measures
Name Time Method Change in concentration of exposure-response AEB071 and AEE800 (a metabolite of AEB071) concentrations compared to cardiac repolarization intervals 24 hours Tolerability of 300 and 900 mg of AEB071. 72 hours
Trial Locations
- Locations (1)
Novartis Investigational Site
🇺🇸Austin, Texas, United States