Ignite Creation Date:
2024-05-05 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00704119
Status:
TERMINATED
Last Update Posted:
2010-03-24
First Post:
2008-06-23
Brief Title:
Study Evaluating the Pharmacokinetic Profile of RhuDex in a Tablet Formulation
Sponsor:
MediGene
Organization:
MediGene
Study Overview
Official Title:
CT 5002 An Open-label Non-randomized Monocentric Phase I Study Evaluating the Pharmacokinetic Profile of RhuDex Using a Tablet Formulation
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Following an SAE study was put on hold After performing preclinical follow-up studies volunteers were no longer available for continuation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RhuDex code number AV1142742 is a novel orally bioavailable low molecular weight modulator of co-stimulation of T lymphocytes RhuDex binds to the protein CD80 also known as B7-1 on the surface of antigen-presenting cells and inhibits its interaction with CD28 but not with CTLA-4 presented by CD4 T lymphocytes
RhuDex is being developed for the treatment of rheumatoid arthritis To improve oral bioavailability the study drug has to be co-administered with an alkaline buffer that increases gastric pH values In previous in vitro and phase I studies meglumine has been identified as the most effective buffer Study CT 5002 is designed to evaluate the bioavailability of four increasing doses of RhuDex combined with a fixed amount of meglumine using a tablet formulation under fed and fasted conditions as well as with co-administration of the proton pump inhibitor pantoprazole Furthermore doseplasma concentration proportionality for single dosing and accumulation effects for repeat dosing of RhuDex will be evaluated
RhuDex is being developed for the treatment of rheumatoid arthritis To improve oral bioavailability the study drug has to be co-administered with an alkaline buffer that increases gastric pH values In previous in vitro and phase I studies meglumine has been identified as the most effective buffer Study CT 5002 is designed to evaluate the bioavailability of four increasing doses of RhuDex combined with a fixed amount of meglumine using a tablet formulation under fed and fasted conditions as well as with co-administration of the proton pump inhibitor pantoprazole Furthermore doseplasma concentration proportionality for single dosing and accumulation effects for repeat dosing of RhuDex will be evaluated
Detailed Description:
This is an open-label non-randomized monocentric Phase I study to evaluate the pharmacokinetic profile of single-dosed and repeat-dosed RhuDex using a tablet formulation as well as to assess the effect of food and the effect with co-administration of a proton pump inhibitor on the bioavailability of RhuDex
12 healthy male subjects will receive study medication in 8 different treatment periods in 4 subsequent steps A B C and D
Within steps A and B the subjects will receive different treatments 4 in A and 2 in B sequentially There will be a wash-out period of at least 4 days between each of the 8 different treatmentstreatment periods of steps A B C and D
In Step A each subject will receive increasing doses of RhuDex in 4 subsequent treatments In Step B each subject will receive 2 different doses of RhuDex preceded by pantoprazole intake in 2 subsequent treatments and in Step C the RhuDex dosing will be preceded by a standardized high-fat high-calorie meal In Step D RhuDex will be administered twice daily for 7 days
For assessing the pharmacokinetic profile of RhuDex in steps A B and C blood samples will be collected prior to and at different intervals after RhuDex administration In step D blood samples will be collected on Days 1 2 4 and 7 Cmin Cmax tmax t½ term CLF AUC0-t and AUC0- of RhuDex will be analyzed
Safety will be evaluated by regular observation and documentation of AEs vital signs physical examination ECG and laboratory parameters
12 healthy male subjects will receive study medication in 8 different treatment periods in 4 subsequent steps A B C and D
Within steps A and B the subjects will receive different treatments 4 in A and 2 in B sequentially There will be a wash-out period of at least 4 days between each of the 8 different treatmentstreatment periods of steps A B C and D
In Step A each subject will receive increasing doses of RhuDex in 4 subsequent treatments In Step B each subject will receive 2 different doses of RhuDex preceded by pantoprazole intake in 2 subsequent treatments and in Step C the RhuDex dosing will be preceded by a standardized high-fat high-calorie meal In Step D RhuDex will be administered twice daily for 7 days
For assessing the pharmacokinetic profile of RhuDex in steps A B and C blood samples will be collected prior to and at different intervals after RhuDex administration In step D blood samples will be collected on Days 1 2 4 and 7 Cmin Cmax tmax t½ term CLF AUC0-t and AUC0- of RhuDex will be analyzed
Safety will be evaluated by regular observation and documentation of AEs vital signs physical examination ECG and laboratory parameters
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