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:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03571594
Eligibility Criteria:
Inclusion Criteria:
* Healthy, adult, male and female (women of non-child bearing potential, surgically sterile) volunteers, 18-55 years of age, inclusive, at screening (Parts A \& B only).
* Healthy, adult, males and female (women of non-child bearing potential), ≥65 years of age at screening (Part C only).
* Healthy, adult, male, 18-40 years of age, inclusive, at screening (Part D only).
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECG abnormalities (All Parts).
* Body mass index (BMI) of ≥18.5 to ≤30 kg/m2 at screening (Parts A, B \& C).
* Body mass index (BMI) of ≥18.5 to \<25 kg/m2 at screening (Part D only).
Exclusion Criteria:
* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
* History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
* History or presence of hypersensitivity or idiosyncratic reaction to the study drugs,excipients or related compounds.
* History or presence of:
1. Gallstones, cholangitis, and/or cholecystitis or clinically significant findings on gallbladder ultrasound as determined by the Principal Investigator;
2. Pancreatitis;
3. Hypothyroidism;
4. Known diabetes mellitus type 1 or type 2;
5. Hypocalcaemia or hypokalemia;
6. Hypoglycemia or hyperglycemia or fasting blood glucose outside normal local range;
7. Thrombocytopenia or other clinically significant hematologic abnormalities;
8. Inflammatory bowel disease, irritable bowel syndrome, or abdominal surgery;
9. Known vitamin B12 deficiency.
10. Abnormal gallbladder ejection fraction on hepatobiliary iminodiacetic acid (HIDA) scan at screening (Part B only)
* Positive urine drug, alcohol or cotinine results at screening or check in.
* Clinically significant serum electrolyte (sodium, potassium, chloride, bicarbonate) abnormalities at screening or each check-in, in the estimation and clinical judgment of the PI or designee.
* Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
* Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg (160/95 mmHg for Part C) at screening.
* Has engaged in strenuous physical exercise in the 48 hours prior first dosing or intends to undergo strenuous physical exercise at any time throughout the study.
* Donation of blood or significant blood loss within 56 days prior to the first dosing.
* Plasma donation within 7 days prior to the first dosing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03571594
Study Brief:
Protocol Section:
NCT03571594