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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02406066
Eligibility Criteria:
Inclusion Criteria:
* Males and females of Non-Childbearing Potential age 18-65
* Have provided written informed consent prior to any study procedures
* Are willing and able to comply with all aspects of the protocol
* Normal or clinically acceptable screening electrocardiogram (ECG)
* Normal blood pressure (systolic: 90-140 mmHg; diastolic 50-90 mmHg) and heart rate (50-100 bpm)
* Smoke at least 10 cigarettes per day (for approximately 1 year or longer)
* Body mass index \> 18.5 and \< 35
Exclusion Criteria:
* Known hypersensitivity to or intolerance of oxazepam or metyrapone, or any benzodiazepine
* Subjects with a low out-of-range serum cortisol value at screening or subjects who, in the investigator's opinion, have a heightened likelihood of having adrenal insufficiency.
* Subjects who have a positive urine drug screen for illegal drugs or other drugs with a high potential for abuse (other than nicotine).
* Inability to communicate or cooperate with the investigator
* History of drug dependence (except nicotine) or psychiatric illness within the past 2 years.
* Subjects with any history of adrenal insufficiency or other adrenal, hypothalamic, or pituitary disorders.
* History of asthma or other respiratory disease, neurologic or neuromuscular disease, or hypotension or cardiovascular disease, that may, in the opinion of the investigator, impact any study procedures or measures, or compromise the safety of the subject.
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02406066
Study Brief:
Protocol Section:
NCT02406066