Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection.
Detailed description
This is an optional sub-study of the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, pharmacokinetic (PK) interactions with standard of care drugs, and biomarkers of drug effect." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing \[68Ga\]CBP8 PET. Eligible participants who consent to the substudy will undergo \[68Ga\]CBP8 PET-CT or \[68Ga\]CBP8 PET-MRI at two time points. Participants will undergo 68Ga-CBP8 PET within 7 days prior to randomization and then again within 7 days prior to day 84 of the phase I study. The hypothesis is that \[68Ga\]CBP8 PET will detect decreased collagen deposition in individuals treated with EGCG compared to placebo.
Interventions
DRUGEGCG 300 mg
Participants will be administered EGCG as part of the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect."
DRUGPlacebo for EGCG 300 mg
Participants will be administered placebo for EGCG as part of the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect."
DRUGEGCG 600 mg
Participants will be administered placebo for EGCG as part of the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect."
DRUGPlacebo for EGCG 600 mg
Participants will be administered placebo for EGCG as part of the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect."
Sponsors
Hal Chapman
Cornell University
Massachusetts General Hospital
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo.
Intervention model description
This is an optional substudy to the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing \[68Ga\]CBP8 PET.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Enrolled in and eligible (based on screening procedures - Visit 1) for the main EGCG Phase 1 study, "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect 2. Signed informed consent
Exclusion criteria
1. Pregnant or breastfeeding (a negative quantitative serum human chorionic gonadotropin (hCG) pregnancy test is required for females having child-bearing potential before the participant can participate)\* 2. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months 3. Determined by the investigator to be clinically unsuitable for the study Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in collagen probe uptake over the entire lungs | From baseline to 12 weeks | Changes in lung collagen uptake will be measured using the PET probe \[68\]Ga-CBP8. Measurements will be made over the entire lungs using standardized uptake values. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFernando Martinez, MD
Weill Medical College of Cornell University
Outcome results
None listed