Summary

for people ages 40-70 (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion
Hal A Chapman

Description

Summary

This is a two part study. In the first part, the pharmacokinetic profile of Epigallocatechin-3-gallate (EGCG) in normal human volunteers given a single oral dose will be determined to set the dose for the second part of the study. In the second part of this study, lung biopsy fragments and urine samples from patients with interstitial lung disease treated with EGCG will be evaluated in biochemical assays and compared to samples from untreated control patients.

Details

This is an interventional study intended to test inhibition of a signaling pathway in vivo in patients with interstitial lung disease, but not intended to affect lung function or disease modifications. Doses of oral Epigallocatechin-3-gallate (EGCG) that achieve plasma levels known to be safe in human volunteers and likely to target fibroblast TGFbeta RI kinase will be established. Disposable fragments of biopsies will be evaluated in biochemical assays including pSmad3 and Snail 1 or assayed to determine lysyl oxidase-like 2 (LOXL2) protein and LOXL2 enzyme activity. Urine collected before and after EGCG exposure will be used to determine whether terminal collagen cross-link breakdown products, termed pyridinoline/deoxypyridinoline (PYD/DPD) are changed from baseline.

Keywords

Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Idiopathic Interstitial Pneumonias Fibrosis Epigallocatechin gallate Epigallocatechin-3-gallate (EGCG)

Eligibility

You can join if…

Open to people ages 40-70

  • Part 1: healthy volunteers
  • Part 2:
  • study will consist of patients presenting to the UCSF interstitial lung disease (ILD) outpatient clinic with imaging indicative of lung fibrosis but of uncertain classification, and who are willing to take EGCG for a minimum of 2 weeks prior to surgery.

You CAN'T join if...

  • co-morbidities affect hepatic function, such as HCV infection, cirrhosis, or
  • using drugs with significant hepatic toxicities

Location

  • UC San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03928847
Phase
Phase 1/2
Study Type
Interventional
Last Updated