Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219882
Status:
COMPLETED
Last Update Posted:
2007-12-25
First Post:
2005-09-16
Brief Title:
Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis
Sponsor:
Ramsey Bonnie MD
Organization:
Ramsey Bonnie MD
Study Overview
Official Title:
A Phase I Safety and Dose Finding Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis Who Are Homozygous for Delta F508 Cystic Fibrosis Transmembrane Conductance Regulator ΔF508 CFTR Mutation
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEER
Brief Summary:
The purpose of this study is to assess the safety of advancing doses of curcuminoids administered orally for fourteen consecutive days in adult subjects with cystic fibrosis CF who are homozygous for ΔF508 CFTR
Detailed Description:
The drug substance being studied is curcumin Curcumin diferuloylmethane is a major constituent in the spice turmeric which is used as a food worldwide
The pharmacologic rationale for studying curcumin for the treatment of cystic fibrosis is the potential for curcumin to help correct a deficiency of the cystic fibrosis transmembrane regulator CFTR protein Cystic fibrosis results from a mutation of the CFTR gene which produces abnormal CFTR protein that does properly transport chloride ion and water in the lung leading to abnormal mucus production Curcumin is a potent inhibitor of the endoplasmic reticulum ER Ca2 pump and lowers ER calcium concentration This may allow abnormal CFTR protein to function properly as a chloride channel and correct the cystic fibrosis defect If this is successful this effect could be measured as a decrease in the nasal potential difference NPD and sweat chloride in cystic fibrosis patients
The primary objective of this study is to assess the safety of advancing doses of curcuminoids administered orally for fourteen consecutive days in adult subjects with cystic fibrosis CF who are homozygous for ΔF508 CFTR The secondary objectives are to obtain pharmacokinetic data for oral curcumoniods in CF subjects and to assess the effectiveness of curcuminoids to alter nasal potential difference NPD and seat chloride concentrations
The pharmacologic rationale for studying curcumin for the treatment of cystic fibrosis is the potential for curcumin to help correct a deficiency of the cystic fibrosis transmembrane regulator CFTR protein Cystic fibrosis results from a mutation of the CFTR gene which produces abnormal CFTR protein that does properly transport chloride ion and water in the lung leading to abnormal mucus production Curcumin is a potent inhibitor of the endoplasmic reticulum ER Ca2 pump and lowers ER calcium concentration This may allow abnormal CFTR protein to function properly as a chloride channel and correct the cystic fibrosis defect If this is successful this effect could be measured as a decrease in the nasal potential difference NPD and sweat chloride in cystic fibrosis patients
The primary objective of this study is to assess the safety of advancing doses of curcuminoids administered orally for fourteen consecutive days in adult subjects with cystic fibrosis CF who are homozygous for ΔF508 CFTR The secondary objectives are to obtain pharmacokinetic data for oral curcumoniods in CF subjects and to assess the effectiveness of curcuminoids to alter nasal potential difference NPD and seat chloride concentrations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None