Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT01662661
Eligibility Criteria:
Inclusion Criteria:
* Must be healthy on the basis of physical examination, medical history, vital signs and the results of blood biochemistry, hematology and coagulation tests and a urinalysis performed (at screening)
* Must have a triplicate 12-lead electrocardiogram consistent with normal cardiac conduction and function
* Must be a non-smoker for at least 3 months prior to selection
* If a female, must be postmenopausal or surgically sterile
* Female participants must have a negative serum pregnancy test (at screening)
Exclusion Criteria:
* Had a past history of heart arrhythmias, history of risk factors for Torsade de Pointes syndrome (an uncommon and distinctive form of polymorphic ventricular tachycardia characterized by a gradual change in the amplitude and twisting of the QRS complexes around the isoelectric line on the electrocardiogram) or having low potassium levels in the blood
* History or suspicion of alcohol, barbiturate, amphetamine, recreational or narcotic drug use that could impact compliance to protocol requirements and/or safety
* Hepatitis A, B or C infection (at screening)
* A positive human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2) test (at screening)
* Have a positive urine drug test or alcohol breath test (at screening)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01662661
Study Brief:
Protocol Section:
NCT01662661