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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT01106469
Eligibility Criteria:
Inclusion Criteria:
* Males, age 18 to 45 years inclusive for Part 1 and age 18 to 55 years inclusive for Parts 2, 3, and 4
* Weight = 60 kilograms and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
* BMI between 30 to 39.9 kg/m2 for obese participants
* Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram (ECG), and clinical laboratory tests performed at screening
* Men must agree to use a double barrier method of birth control (e.g. condom and use of spermicide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Willing to adhere to the prohibitions and restrictions specified in this protocol
Exclusion Criteria:
* History of, or currently active, significant illness or medical disorders, including (but not limited to) cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), endocrine or metabolic disease (e.g. hyper/hypo-thyroidism), hematological disease (e.g. von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders (including retinal disorders or cataracts), neoplastic disease, skin disorder, or any other illness that the Investigator considers should exclude the participant
* Participants at risk for QTc prolongation (specific heart rhythm irregularity)
* Within 12 months prior to screening, has had a clinically important, serious infection (e.g. hepatitis, pneumonia, or pyelonephritis), has been hospitalized for an infection or has been treated with intravenous (IV) antibiotics for an infection
* Smoker or tobacco user within the past 3 months
* History of alcohol or drug abuse
* History of clinically significant drug and/or food allergies, including allergies or intolerance (e.g. lactose intolerance)
* Donation of 1 or more units of blood or acute loss of an equivalent amount of blood within 60 days prior to study drug administration
* Received an experimental drug or used an experimental medical device within 60 days
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01106469
Study Brief:
Protocol Section:
NCT01106469