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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01395433
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 19 kg/m2 and 29 kg/m2, inclusive
* The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
Exclusion Criteria:
* The subject has taken disallowed medication within 1 week prior to the first dose of investigational medicinal product (IMP), or within 5 half-lives prior to inclusion for any medication ingested, whichever is longer
* The subject has a significant history of drug or alcohol abuse
* The subject has taken any investigational products within 3 months prior to the first dose of IMP
* The subject has a history of or presence of any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder
* The subject has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years prior to the first dose of IMP
* The subject has a history of abdominal surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or nonperipheral vascular surgery within 6 months prior to the first dose of IMP
* The subject has any concurrent illness that may affect the particular target or metabolism of the IMP
* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01395433
Study Brief:
Protocol Section:
NCT01395433