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Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect
Sponsor: Hal Chapman
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.
Official title: Collagen-targeted PET Imaging for Assessment of EGCG Effect
Key Details
Gender
All
Age Range
40 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2024-02-07
Completion Date
2026-03-25
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
EGCG 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."
Placebo 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."
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."
Placebo 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."
Locations (3)
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Virginia
Charlottesville, Virginia, United States