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Study Evaluating the Pharmacokinetic Profile of RhuDex® in a Tablet Formulation

NCT00704119 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-03-24

No results posted yet for this study

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, dose/plasma concentration proportionality for single dosing and accumulation effects for repeat dosing of RhuDex® will be evaluated.

Conditions

  • Pharmacokinetics

Interventions

DRUG

RhuDex®

* Treatment A.1: 31.65 mg RhuDex® once N=12 * Treatment A.2: 63.33 mg RhuDex® once N=12 * Treatment A.3: 126.63 mg RhuDex® once N=12 * Treatment A.4: 253.26 mg RhuDex® once N=12 * Treatment B.1: 31.65 mg RhuDex® once N=12 * Treatment B.2: selected dose of RhuDex® once N=12 * Treatment C: selected dose of RhuDex® once N=12 * Treatment D: selected dose of RhuDex® twice daily for 6 days N=12

Sponsors & Collaborators

  • MediGene

    lead INDUSTRY

Principal Investigators

  • Stuart Mair, MBChB, DROCG,DCPSA · Syneos Health

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704119 on ClinicalTrials.gov