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Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®

2014-08-27 03:36:06 | BioPortfolio

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.

Description

RhuDex® is a novel, orally bioavailable, low molecular weight modulator of co-stimulation of T lymphocytes. RhuDex® binds to the protein CD80 on the surface of antigen-presenting cells and inhibits its interaction with CD28 (but not with CTLA-4) presented by CD4+ T lymphocytes.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Pharmacokinetics

Intervention

RhuDex®

Location

Charles River Clinical Services Edinburgh Ltd
Edinburgh
United Kingdom
EH14 4AP

Status

Completed

Source

MediGene

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:36:06-0400

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Medical and Biotech [MESH] Definitions

Agents that aid or increase the action of the principle drug (DRUG SYNERGISM) or that affect the absorption, mechanism of action, metabolism, or excretion of the primary drug (PHARMACOKINETICS) in such a way as to enhance its effects.

Naturally occurring genetic variations associated with drug response (e.g., dosage, extent and rate of metabolic processes). While these variants are not markers for GENETIC PREDISPOSITION TO DISEASE they influence PHARMACOKINETICS and pharmacodynamics and often occur on genes encoding drug metabolism enzymes and transporters (e.g., ANGIOTENSIN CONVERTING ENZYME; CYTOCHROME P-450 CYP2D6).

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