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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT00991718
Eligibility Criteria:
Inclusion Criteria
* Female
* Non-childbearing potential
* Body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
* In good health, determined by no clinically significant findings on physical examination, medical history, 12-lead ECG, and vital signs
* Negative test for drugs of abuse at screening (does not include alcohol) and at admission to the clinical research facility (does include alcohol)
Exclusion Criteria
* History or clinical manifestations of clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), urologic, neurologic, inflammatory, or psychiatric disorders, or cancer
* History of symptomatic hypotension, idiopathic orthostatic hypotension, or other autonomous-failure syndromes
* History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to Day -1
* History of stomach or intestinal surgery, stomach disease, or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy are allowed)
* History of alcoholism, drug abuse, or drug addiction (including soft drugs like cannabis products)
* Use of any prescription medications/products, including known enzyme-inducing/inhibiting agents, over-the-counter medication, or other non-prescription preparations (including supplements, vitamins, minerals, phytotherapeutic/herbal/ plant-derived preparations, the tryptophans, and St. John's wort or other hypericum perforatum-containing substance) within 2 weeks prior to Day -1, with the exception of hormone-replacement therapy
* Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 60 days prior to Day -1 or within 5 times the elimination half-life of the respective drug; participation in a trial involving administration of \^1\^4C-radiolabeled compound(s) within 6 months prior to Day -1; participation in more than two other drug trials within 1 year prior to Day -1
* Receipt of any vaccination or immunization within 1 month prior to Day -1
* Use of any nicotine-containing or nicotine-replacement products within 6 months prior to Day -1
* Consumption of alcohol or methylxanthine-containing beverages or food
* Receipt of blood products within 2 months prior to Day -1
* Donation of \> 100 mL of blood within 60 days prior to Day -1; donation of \> 1.0 litres of blood within 10 months prior to Day -1
* Irregular defecation pattern, i.e., less than once per 2 days within 6 months prior to Day -1; acute constipation problems within 3 weeks prior to Day -1 (Part B subjects only)
* Poor peripheral venous access
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00991718
Study Brief:
Protocol Section:
NCT00991718