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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT01036061
Eligibility Criteria:
Inclusion Criteria:
* Healthy Males and Females between the ages of 18-50 years old
* Male and Female subjects must agree to use protocol specified contraceptive methods.
* Male subjects only in PET parts of the study.
* Capable of providing written informed consent.
Exclusion Criteria:
* A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
* Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.
* Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting).
* Screening ECG parameters outside the protocol specified parameters.
* Pulse rate \<50 or \>100 bpm OR a systolic blood pressure \>140 or \<95 mmHg OR a diastolic blood pressure \>90 or \<50 mmHg at screening and/or baseline.
* Pregnant or lactating females.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden.
* Significant suicidal risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01036061
Study Brief:
Protocol Section:
NCT01036061