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 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT02546635
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / \[Height (m)\]2.
* Subjects must not be vegetarians or consume abnormal diets.
* Subject with no clinically significant abnormal serum biochemistry, haematology coagulation (Part B only) and urine examination values within 21 days of the first dose.
* Subject with a negative urinary drugs of abuse screen, determined within 21 days of the first dose (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
* Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
* Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 21 days of the first dose.
* Subject with no history of autoimmune disease, cardiac disease, kidney disease or any food intolerance.
* Male subject willing to use 2 effective methods of contraception i.e. established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
* Subjects must be available to complete the study (including follow-up visit).
* Subjects must satisfy a medical examiner about their fitness to participate in the study
* Subjects must provide written informed consent to participate in the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02546635
Study Brief:
Protocol Section:
NCT02546635