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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT00500461
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects;
* Between the ages of 18-55 years, inclusive
* Body mass index within the range 18.0 to 30.0 kg/m2.
* Non-smokers
* Adequate venous access for intermittent cannulation
* A signed and dated written informed consent is obtained from the subject
* The subject is capable of giving informed consent
* Available to complete the study
Exclusion Criteria:
* Any clinically important abnormality identified in the following: at the screening medical assessment
* A mean QTc(B) value at screening \>450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
* A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
* A mean heart rate outside the range of 40-90 bpm at screening.
* History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
* The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
* The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort.
* The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
* The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
* The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT00500461
Study Brief:
Protocol Section:
NCT00500461