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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT01416350
Eligibility Criteria:
Inclusion Criteria:
* Male or female between 18 and 65 years of age inclusive
* Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy
* Child-bearing potential and agrees to use one of the contraception methods
* Body weight ≥ 50 kg and body mass index (BMI) within the range 18.5 - 30 kg/m2 (inclusive)
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions
* Single QT duration corrected for heart rate by Bazett's formula (QTcB) \< 450 msec.
Exclusion Criteria:
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities
* A positive pre-study drug/alcohol screen
* A positive test for HIV antibody
* History of regular alcohol consumption within 6 months of the study
* The subject has participated in a clinical trial and has received an investigational product within the 3 months
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements
* History of sensitivity to any of the study medications, or erythromycin, any macrolide or ketolide antibiotic
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
* The subject has donated blood in the 3 months prior to the study
* Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing
* Lactating females
* Unwillingness or inability to follow the procedures outlined in the protocol
* Subject is mentally or legally incapacitated
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01416350
Study Brief:
Protocol Section:
NCT01416350