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 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT01721135
Eligibility Criteria:
Inclusion Criteria:
* Male or female between 18 and 65 years of age inclusive
* Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5x Upper limit of normal (ULN)
* Healthy as determined by a physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
* A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal . Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods. Those of child-bearing potential must agree to use one of the protocol contraception methods.
* Body mass index (BMI) within the range 18.5-29.0 kg/m2 (inclusive)
* Capable of giving written informed consent
* Current non-smokers who have not used tobacco products in the 6 month period preceding screening
* No significant abnormality on 12-lead electrocardiogram (ECG) at screening
* A 24 hour Holter ECG at screening that demonstrates no clinically significant abnormalities
Exclusion Criteria:
* A physician deems the subject unsuitable for the study
* A screening Holter ECG tracing that reveals clinically concerning arrhythmias
* A blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
* A mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
* History or presence of any medically significant disease, or any disorder. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
* A positive result for Hepatitis B or Hepatitis C 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 Human Immunodeficiency Virus (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 3 months of the first dosing day in the current study
* 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 from 14 days before screening until the follow-up visit unless permitted by the investigator
* History of sensitivity to any of the study medications
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 3 month period
* Pregnant females
* 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:
NCT01721135
Study Brief:
Protocol Section:
NCT01721135