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 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT03527095
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and non-pregnant, non-lactating female subjects
* Aged 18 to 55 years
* Body mass index of 18.0 to 32.0 kg/m2
* Must agree to the use of an adequate method of contraception
Exclusion Criteria:
* Subjects who have received any IMP in a clinical research study within the previous 3 months
* History of any drug or alcohol abuse in the past 2 years
* Current smokers and those who have smoked within the last 12 months.
* Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level \>1.5 x upper limit of normal at screening
* Abnormal renal function at screening
* Clinically significant abnormal biochemistry, haematology, coagulation profile or urinalysis
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder.
* Subjects with a history of gall stones or abdominal surgery eg cholecystectomy
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedy (including known inhibitors or inducers of CYP3A4
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03527095
Study Brief:
Protocol Section:
NCT03527095