Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®

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


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.


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






Charles River Clinical Services Edinburgh Ltd
United Kingdom
EH14 4AP





Results (where available)

View Results


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

Clinical Trials [129 Associated Clinical Trials listed on BioPortfolio]

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

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)...

Population Pharmacokinetics of Dexmedetomidine in ICU Patients

Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedeto...

Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer

This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal f...

Pharmacokinetics and Pharmacodynamics of Rocuronium in Closed-Loop Infusion System

To explore and compare the effects of propoful, sevoflurane, and a combination of both on the pharmacokinetics and pharmacodynamics of rocuronium. To discover and confirm sex differences ...

An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron

This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.

PubMed Articles [692 Associated PubMed Articles listed on BioPortfolio]

Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis.

Elagolix is a novel, orally active, non-peptide, competitive gonadotropin-releasing hormone (GnRH) receptor antagonist in development for the management of endometriosis with associated pain and heavy...

Influence of Inflammation on the Pharmacokinetics of Perampanel.

It is well-known that the pharmacokinetics of various drugs are influenced by inflammation. This study evaluated the relationship between C-reactive protein (CRP; an inflammation marker) and the pharm...

Clinical Pharmacokinetics and Dose Recommendations for Posaconazole in Infants and Children.

The objectives of this study were to investigate the population pharmacokinetics of posaconazole in immunocompromised children, evaluate the influence of patient characteristics on posaconazole exposu...

Prediction of Human Pharmacokinetics of Ulixertinib, a Novel ERK1/2 Inhibitor from Mice, Rats, and Dogs Pharmacokinetics.

Ulixertinib (BVD-523) is a novel and selective reversible inhibitor of ERK1/ERK2. The primary objectives of the study were to evaluate the pharmacokinetics of ulixertinib in mice, rats, and dogs follo...

Impact of the CYP3A5*1 Allele on the Pharmacokinetics of Tacrolimus in Japanese Heart Transplant Patients.

Tacrolimus, a major immunosuppressant used after transplantation, is associated with large interindividual variation involving genetic polymorphisms in metabolic processes. A common variant of the cyt...

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).

More From BioPortfolio on "Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®"

Quick Search


Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial