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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT01164332
Eligibility Criteria:
Inclusion Criteria:
Subjects meeting the following conditions will be eligible for enrolment:
* Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
* Caucasian
* Age: 20 to 45 years
* BMI 20 - 26 kg.m-2
* Healthy based on the pre-study examination
* Suitable veins for easy cannulation
* Willing and able to provide informed consent
Exclusion Criteria:
Subjects of any of the following categories will be excluded from enrolment:
General - all subjects
* Previous participation in the trial
* Participant in any other trial during the last 90 days
* Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
* History of any clinically relevant allergy
* Presence of any acute or chronic infection
* Presence or history of any relevant co-morbidity
* Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
* Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
* Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
* Positive serology for HBsAg, anti HBc and anti HCV
* Positive HIV test
* Positive alcohol or urine drug test on recruitment
* History of alcohol and/or drug abuse and/or daily use of \> 30 g alcohol
* Smoking more than 10 cigarettes/day or equivalent of other tobacco products
* Use of prohibited medication
* Suspicion or evidence that the subject is not trustworthy and reliable
* Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
General - all females
* Positive pregnancy test
* Lactating
* Not using appropriate contraception in premenopausal women
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01164332
Study Brief:
Protocol Section:
NCT01164332