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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT01294566
Eligibility Criteria:
Inclusion Criteria:
* AST, ALT, alkaline phosphatase and bilirubin \< or =1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Healthy as determined by a responsible and experienced physician
* Male or female between 18 (20 for Japanese) and 65 years of age inclusive
* Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods
* Body weight \> or = 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (inclusive).
* Capable of giving written informed consent
* Average QTc, QTcB or QTcF \< 430 msec.
* For Japanese subjects Japanese ancestry defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese.
Exclusion Criteria:
* Hepatitis B or Hepatitis C positive
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* A positive pre-study drug/alcohol screen.
* HIV positive
* History of regular alcohol consumption within 6 months of the 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 (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) prior to the first dose of study medication
* History of sensitivity to any of the study medications, or components thereof
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Pregnant females
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Subject is mentally or legally incapacitated.
* Regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
* Subjects will be screened such that those subjects exhibiting rapid gastric emptying rates (t½b \< 75 min) will be excluded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01294566
Study Brief:
Protocol Section:
NCT01294566