This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Pirfenidone will be administered as per the dosage schedule mentioned in arm description.
Vismodegib will be administered as per the dosage schedule mentioned in arm description.
Scripps Clinic
La Jolla, California, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
Percentage of Participants with Serious and Non-Serious Adverse Events
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. A serious adverse event is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline up to 28 weeks
Percentage of Participants with Discontinuation of Any Study Medication Due to a Drug-Related Adverse Event
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. Relatedness to the study drug will be assessed by the investigator.
Time frame: Baseline up to 28 weeks
Percentage of Participants with Dose Modifications Due to Laboratory Abnormalities and Adverse Events
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship.
Time frame: Baseline up to 28 weeks
Percentage of Participants with Clinically Meaningful Laboratory Abnormalities as Assessed by Investigator
Vital signs and laboratory parameters will be evaluated, and percentage of participants with any clinically meaningful abnormalities as assessed by Investigator will be reported. Laboratory abnormalities of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade greater than (\>) 3 will be considered clinical meaningful.
Time frame: Baseline up to 28 weeks
Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4)
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Suburban Lung Associates
Elk Grove, Illinois, United States
Medical Consultants, PC ; Pulmonary
Muncie, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University Medical School
New Orleans, Louisiana, United States
Steward St. Elizabeth's Medical Center ; Pulmonary, Critical Care and Sleep Medicine
Boston, Massachusetts, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Allied Clinical Research
Reno, Nevada, United States
Atlantic Respiratory Institute
Summit, New Jersey, United States
...and 5 more locations
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + alpha-1-acid glycoprotein (AAG)-bound vismodegib plasma concentration.
Time frame: Predose (0 hour) at Week 4
Total and Free Trough Plasma Concentrations of Vismodegib at Week 12 (Cmin, Wk12)
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
Time frame: Predose (0 hour) at Week 12
Total and Free Trough Plasma Concentrations of Vismodegib at Week 24 (Cmin, Wk24)
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
Time frame: Predose (0 hour) at Week 24
Total and Free Trough Plasma Concentrations of Vismodegib at Safety Follow-up Visit (Cmin, SFU)
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
Time frame: At Day 30 post last dose (last dose = 24 weeks) (up to 28 weeks)