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:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01033318
Eligibility Criteria:
Inclusion Criteria:
Part 1:
* Nonsmoker for at least 6 months
* Body Mass Index (BMI) less than or equal to 29 kg/m2
* In overall good health
Part 2:
* Body Mass Index (BMI) greater than 18kg/m2 and less than or equal to 35kg/m2
* In overall good health (patients with hypertension and/or hyperlipidemia are accepted)
Exclusion Criteria:
Part 1:
* History of any cardiovascular disease or any clinically significant family history of cardiac arrhythmias or conduction abnormalities at an age less than 60 years
* History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
* History of cancer
* Clinically significant history of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
* Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
* History of asthma, severe wheezing, COPD, or other pulmonary disease
* Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
* Major surgery, donated blood or participated in another investigational drug(s) trial within 30 days
* Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
* Nitrate therapy within 4 weeks
* History of significant drug allergy or history of food allergies
Part 2
* History of any clinically significant cardiac or cardiovascular disease (other than hypertension)
* History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
* History of cancer
* History of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
* Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
* History of asthma, severe wheezing, COPD, or other pulmonary disease
* Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
* Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
* Surgery, significant blood loss, donated blood, or participated in another investigational drug(s) trial within 30 days
* Nitrate therapy within 4 weeks
* History of significant drug allergy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01033318
Study Brief:
Protocol Section:
NCT01033318