The study team hypothesizes that intermittent (3 doses administered over 3 consecutive days in 3 consecutive weeks) oral administration of combination Dasatinib (100 mg/d) + Quercetin (1250 mg/d) will be safe and well tolerated in patients with IPF. Treatment with D+Q will result in reduced abundance of pro-inflammatory cells within subjects over baseline. Finally, the reduction in biomarkers of cellular pro-inflammatory state will be related to no change in functional and patient reported outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
26
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Percentage of pro-inflammatory expressing cells
A skin biopsy will be obtained at baseline and the percentage of pro-inflammatory expressing cells will be recorded
Time frame: baseline
Percentage of pro-inflammatory expressing cells
A skin biopsy will be obtained at 4 weeks post baseline/5 days after the last dose of study medication and the percentage of pro-inflammatory expressing cells will be recorded
Time frame: 4 weeks post baseline visit biopsy/ 5 days post last dose study drug
Blood Pressure
Time frame: screening 1 week pre baseline visit
Blood Pressure
Time frame: baseline visit
Blood Pressure
Time frame: 4 weeks post baseline
Weight
Time frame: screening 1 week pre baseline visit
Weight
Time frame: baseline visit
Weight
Time frame: 4 weeks post baseline
Heart Rate
Time frame: screening 1 week pre baseline visit
Heart Rate
Time frame: baseline visit
Heart Rate
Time frame: 4 weeks post baseline
CBC (complete blood count)
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Time frame: screening 1 week pre baseline visit
CBC (complete blood count)
Time frame: 4 weeks post baseline
Lipid Panel
Time frame: screening 1 week pre baseline visit
Lipid Panel
Time frame: 4 weeks post baseline
HbA1c (glycated hemoglobin)
Time frame: screening 1 week pre baseline visit
HbA1c (glycated hemoglobin)
Time frame: 4 weeks post baseline
CMP (comprehensive metabolic panel)
Time frame: screening 1 week pre baseline visit
CMP (comprehensive metabolic panel)
Time frame: 4 weeks post baseline
Plasma hsCRP (high-sensitivity C-reactive protein)
Time frame: screening 1 week pre baseline visit
Plasma hsCRP (high-sensitivity C-reactive protein)
Time frame: 4 weeks post baseline
Plasma IL-6 (inflammatory biomarker)
Time frame: baseline
Plasma IL-6 (inflammatory biomarker)
Time frame: 4 weeks post baseline
Plasma IL-6R (inflammatory biomarker)
Time frame: baseline
Plasma IL-6R (inflammatory biomarker)
Time frame: 4 weeks post baseline
Plasma PASP biomarkers (inflammatory biomarkers)
Time frame: baseline
Plasma PASP biomarkers (inflammatory biomarkers)
Time frame: 4 weeks post baseline
p16INK4a biomarker (inflammatory biomarker)
Time frame: baseline
p16INK4a biomarker (inflammatory biomarker)
Time frame: 4 weeks post baseline