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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT00432068
Eligibility Criteria:
Inclusion criteria:
* Male or female from 18-60 years of age, cholecystectomized at least 4 months prior to the start of the study.
* In a good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening
* Body mass index within 19-29 kg/m2
* Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion criteria:
* Any clinically significant abnormal laboratory values at screening, or evidence of clinically significant abnormal findings at the physical exam at screening, or significant illness within 2 weeks prior to dosing
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated)
* History of clinically significant drug allergy, history of atopic allergy, history or clinical evidence of pancreatic injury or pancreatitis, clinical evidence of liver disease or liver injury , history or presence of impaired renal function, or history of urinary obstruction or difficulty urinating
* History of immunocompromise, including a positive HIV
* Known positive hepatitis B or C surface antigen (HBsAg) or Hepatitis C test result (anti-HCV)
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays at screening
* Female subjects who are pregnant or lactating, or are of childbearing potential and without a medically acceptable and highly effective method for birth control.
* Demonstrating intolerance to octreotide at baseline
* Any subject who has a known history of diabetes mellitus in parents or grandparents.
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00432068
Study Brief:
Protocol Section:
NCT00432068