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 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT01051505
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated, written informed consent
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
* Healthy male or female (of non child bearing potential)volunteers with suitable veins for cannulation or repeated venepuncture
Exclusion Criteria:
* Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate
* Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
* Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01051505
Study Brief:
Protocol Section:
NCT01051505