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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01461512
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Men aged between 18 and 46 years (inclusive)
* Nonsmoker for more than 3 months
* Body mass index between 18 and 27 kg/m2
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Negative results from urine drug screen if performed
* Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study
Exclusion Criteria:
* Known hypersensitivity to the study drug or any excipients of the drug formulation
* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment with another investigational drug within 3 weeks prior to screening
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
* Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
* Treatment in the previous 3 weeks with any drug including over-the-counter drugs (including herbal medicines such as St John's Wort)
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Blood donation during the previous 3 weeks
* Any metallic, electric, electronic or magnetic device or object not removable
* Claustrophobia
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
46 Years
Study:
NCT01461512
Study Brief:
Protocol Section:
NCT01461512