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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT01174056
Eligibility Criteria:
Inclusion Criteria:
* Healthy man or woman, any race or ethnicity, age 19 - 44 years old
* Screening FEV1 and FVC \> 90% of predicted
* Screening oxygen saturation by pulse oximetry \>97% on room air
* Capable of lying still and supine within the PET/CT scanner for \~1.5 hours
* Capable of following instructions for breathing protocol during CT portion of PET/CT
* Able and willing to give informed consent
* BMI \< 35
Exclusion Criteria:
* Pregnancy (confirmed by qualitative urine hCG pregnancy test)
* Lactation
* Active menstruation
* History of cardiopulmonary disease
* Currently taking any prescription medications
* History of tobacco use or illicit drug use within the past year
* Presence of implanted electronic medical device
* Enrollment in another research study of an investigational drug
* Known allergy to rosiglitazone or zileuton
* Known allergy to both trimethoprim/sulfamethoxazole and amoxicillin
* Known allergy to drugs routinely used during bronchoscopy
* History of chronic active liver disease or acute liver disease within the past 3 months
* SGOT \>47 IU/L, SGPT \> 53 IU/L, or bilirubin \> 1.1 mg/dl
* Inability lie flat for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT
* Prior research-related radiation exposure within the past year such that participation in this study would result in exposures that exceed the limits as defined by the FDA RDRC regulations (21 CFR 361.1).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
44 Years
Study:
NCT01174056
Study Brief:
Protocol Section:
NCT01174056