Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose Tolerance (NCT02955888) | Clinical Trial Compass
TerminatedPhase 2
Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose Tolerance
Stopped: Unsatisfactory rate of recruitment
Canada11 participantsStarted 2017-01-03
Plain-language summary
This is a Phase 2, multi-center, double blind, placebo controlled study to evaluate the safety and tolerability of PBI-4050, and its effects on the pancreatic, pulmonary functions and on various biomarkers in Cystic Fibrosis patients with abnormal glucose tolerance. Patients with abnormal glucose tolerance have elevated glucose level either at 1 hour or 2 hour during an Oral Glucose Tolerance Test (OGTT). The Main study will include 24 weeks of treatment with PBI-4050 or matching placebo. At the end of the treatment period, patients will have the option of participating in a 24-week Extension study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is 18 years of age or older at screening.
✓. Patient has a documented and confirmed CF diagnosis.
✓. Patient has performed an OGTT for diagnosis of INDENT, IGT and de novo CFRD within 12 months prior to screening visit.
✓. Patient has a Body Mass Index (BMI) of at least 17 kg/m2.
✓. Patient has signed written informed consent.
✓. Patient is able and willing to self-monitor blood glucose level at home.
✓. Female patients of childbearing potential must have a negative pregnancy test (serum or urine) and agree to use adequate birth control from screening throughout the study and for the 30 days after the last study drug administration.
✓. If a male patient has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for the 30 days after the last study drug administration.
Exclusion criteria
What they're measuring
1
Number of Subjects with Adverse Events (Combined Main Study and Extension Study Participation)
✕. Patient has recent or ongoing infection requiring intravenous treatment with an anti-infective agent within 30 days before screening.
✕. Patient is concurrently taking high dose of ibuprofen (\>30 mg/kg) or is using corticosteroids (except inhaled and topical corticosteroids).
✕. Patient is currently using weight-loss medications.
✕. 4\. Patient has used any moderate/potent inhibitor of cytochrome P450 (CYP) 2C9 isozyme or strong inhibitor of CYP3A isozyme within 30 days prior to the first study drug administration.
✕. Patient has significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 Upper Limit of Normal (ULN) or total bilirubin above ULN at screening.
✕. Patient has a history of chronic alcohol or other substance abuse as determined at screening that may prevent study compliance based on Investigator judgment.
✕. History of malignancy of any organ system, treated or untreated, within the past 5 years other than basal or squamous cell skin cancer.
✕. Patient has unstable chronic heart failure that has required change in therapy within 2 months prior to screening.