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Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®

NCT00532012 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2008-07-16

No results posted yet for this study

Summary

The drug that is under investigation during this study is RhuDex® and is expected to be used as an oral treatment for rheumatoid arthritis. Normal stomach juices contain acid and previous studies have shown that this acidity reduces the solubility and therefore the absorption of RhuDex®. Administering the alkaline buffer meglumine with RhuDex® has shown to increase the solubility of RhuDex® by decreasing the stomach acidity.

The purposes of this study are to determine:

* the optimum level of meglumine which is required to achieve the best uptake of RhuDex® from the stomach into the blood
* to determine the concentration of RhuDex® in the blood in the presence of the optimum level of meglumine
* to investigate further the safety and tolerability of RhuDex®. The study will be conducted in healthy male volunteers.

Conditions

  • Pharmacokinetics

Interventions

DRUG

RhuDex®

Sponsors & Collaborators

  • MediGene

    lead INDUSTRY

Principal Investigators

  • Stephen Freestone, MD · Syneos Health

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-10-31
Completion
2007-11-30

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 NCT00532012 on ClinicalTrials.gov