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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00651534
Eligibility Criteria:
Inclusion criteria:
* Healthy postmenopausal women
* Non-smokers
* Body weight \> or = 50 kg and BMI within the range 19-32 kg/m2
* Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form
* QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block
* Hispanic or non-Hispanic (Caucasian) ethnicity
Exclusion criteria:
* Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study
* Positive urine drug screen at screening
* Positive urine test for alcohol at pre-dose
* Positive for HIV or hepatitis B or C virus at screening
* Urinary cotinine levels indicative of smoking at screening
* History of smoking or use of nicotine containing products within one year of the study or \>10 pack-year history of smoking overall
* History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
* History of drug abuse within 6 months of the study
* Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs
* Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication
* Donation of blood in excess of 500 mL within 56 days prior to dosing
* Evidence of renal, hepatic or biliary impairment
* History of serious gastrointestinal disease
* History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
* History of clinically significant cardiovascular disease
* Medical conditions that might alter bone metabolism
* Serum parathyroid hormone (iPTH) test levels outside the reference range at screening
* Liver function tests, parathyroid hormone test or CPK outside the reference range at screening
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT00651534
Study Brief:
Protocol Section:
NCT00651534