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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00906256
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males or healthy females of non-child bearing potential
2. Aged 18-65 years;
3. Body Mass Index (BMI) of 18-32kg/m2;
4. Normal electrocardiograms (ECGs) or with clinically insignificant abnormalities in the opinion of the Investigator;
5. Normal vital signs or with clinically insignificant abnormalities in the opinion of the Investigator;
6. Clinically normal physical findings and safety laboratory values at the time of the screening visit, as judged by the Investigator;
7. Must be willing and able to participate in the whole study and must provide written informed consent.
Exclusion Criteria:
1. Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months;
2. Subjects who have previously been enrolled in this study;
3. A past or current disease, which as judged by the Investigator, could affect the subject's participation in or the outcome of the study. These diseases include, but are not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease;
4. Subjects who have ever sought advice from or been referred to a GP or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents;
5. Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months;);
6. Positive drugs of abuse test result (Appendix 1, Section 20);
7. Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 Unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine);
8. Smoking of more than 10 cigarettes per day and the inability to refrain from smoking during confinement;
9. Females of child bearing potential, as detailed in Section 9.4;
10. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the PI (Appendix 1, Section 20);
11. History of adverse reaction or allergy to study drug or its excipients. If the subject suffers from hayfever they must not have or be expecting to have symptoms during the study period;
12. Subjects with known present or past medical history, or family history (as far as known by the subject) of any of the following cardiovascular findings:
* 2nd degree AV-block (type II) or 3rd degree AV-block and/or other relevant arrhythmias
* Prolonged QT-interval syndrome or other cardiac conduction disorder QTc \> 450 ms
* PR interval outside range of 120 - 220 ms
* Evidence of clinically significant T wave abnormalities
13. Donation of blood within the previous three months;
14. Subjects will be excluded from the study if they are considered by the PI to be at risk of transmitting, thorough blood or other body fluids, the agents responsible for acquired immunodeficiency syndrome (AIDS) or other sexually transmitted disease or hepatitis;
15. Positive HBV, HCV or HIV results;
16. Excessive use of caffeine (more than five cups of coffee or equivalent per day);
17. Subjects receiving prohibited medication as described in Section 9.5;
18. Subjects with planned surgery, dental procedure or hospitalisation during the study;
19. Failure to satisfy the PI of fitness to participate for any other reason.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00906256
Study Brief:
Protocol Section:
NCT00906256