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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT06889168
Eligibility Criteria:
Inclusion Criteria:
* Women 18 through 64 years of age (inclusive)
* Pulmonary Function Test (PFT) with following criteria:
1. DLCO \>20% predicted and FVC \<90% OR
2. Post bronchodilator FEV1 between 30% and 90% predicted.
* Confirmed or possible diagnosis of LAM
* Willing to avoid grapefruit juice and St. John's wort while in the study
* Able and willing to comply with the study procedures
Exclusion Criteria:
* Women who have or will undergo a transplant
* Women who will undergo surgery
* Women who are currently pregnant or plan on a pregnancy
* Women who are currently breast feeding or lactating
* Dementia or other cognitive dysfunction that, in the opinion of the investigator, would prevent the participant from consenting to the study or completing study procedures
* Currently taking any of the following medications:
* Antifungal Medications: Ketoconazole; Itraconazole ; Voriconazole.
* Antibiotics for bacterial infections: Clarithromycin.
* Analgesics to treat headaches/migraines: Dihydroergotamine; Dihydroergotamine intranasal
* Antiretroviral protease inhibitors used in human immunodeficiency virus (HIV) infections: Atazanavir ; Nelfinavir; Indinavir; Ritonavir; Saquinavir
* Anti-epileptic or seizure medications: Carbamazepine, Fosphenytoin; Oxcarbamazepine; Phenobarbital ; Phenytoin; Primidone
* Anti-depressant medications: Nefazodone; St. John's wort
* Targeted cancer drugs: Regorafenib; Venetoclax ; Cobimetinib
* Ivabradine (used to treat chronic heart failure); Telithromycin (used to treat community acquired pneumonia); Lomitapide (treatment of familial hypercholesterolemia); Lonafarnib (Hutchinson-Gilford progeria syndrome); conivaptan (treat low sodium levels); flibanserin (management of hypoactive sexual desire disorder (HSDD)); Naloxegol (opioid-induced constipation); Warfarin (prevent blood clots); Lurasidone (schizophrenia and bipolar depression); Eliglustat (treatment of Gaucher's disease).
* Non English speaking, illiterate, or other vulnerable persons will not be included among study subjects.
* Any condition that in the opinion of the investigator might adversely influence the study outcome.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT06889168
Study Brief:
Protocol Section:
NCT06889168