The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
University of Alabama at Birmingham
Birmingham, Alabama, United States
Safety
Number of participants with adverse events
Time frame: Week 4
Long-term safety
Number of participants with adverse events
Time frame: Weeks 52-104
Disease progression/death rates
Time to disease progression and death
Time frame: Up to week 56
Disease progression/death rates
Time to disease progression and death from week 52
Time frame: Weeks 52-104
Pharmacokinetics-Cmax
Maximum observed concentration in plasma
Time frame: Week 1 (baseline) and week 2
Pharmacokinetics-Cmin
Minimum observed concentration in plasma
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics-AUC
Area under the plasma concentration - time curve
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics-Tmax
Time to reach Cmax
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics - t 1/2
Terminal half-life (t1/2)
Time frame: Week 0 (baseline) and week 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1
UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine
Sacramento, California, United States
Stanford University, Pulmonary & Critical Care Clinic
Stanford, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
University of Louisville
Louisville, Kentucky, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Mount Sinai Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
...and 12 more locations
Pharmacokinetics-Vz/f
Apparent volume of distribution
Time frame: Week 0 (baseline) and week 2
Pharmacokinetics-CL/F
Apparent total body clearance
Time frame: Week 0 (baseline) and week 2