Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®

July 15, 2008 updated by: MediGene

An Open-Label, Partially Randomized, Cross-Over, Monocentric Phase I Study Evaluating the Pharmacokinetic Profile of RhuDex® in Order to Determine Optimum Doses of Meglumine and RhuDex®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects between 18 and 60 years at the time of enrollment
  • Male volunteers and their partners who are of child-bearing potential must agree to use a double-barrier method of contraception during the study and for 12 weeks after discharge
  • BMI between 18.5 and 29.9 kg/m²
  • Written informed consent
  • Ability to comply with the requirements of the study

Exclusion Criteria:

  • Acute infection at time of enrollment
  • History of chronic inflammation, chronic infection, other chronic disease, autoimmune disorders (e.g. diabetes mellitus) or cancer
  • Clinical significant abnormal ECG
  • Clinical significant abnormal laboratory values (especially in terms of liver or renal insufficiency)
  • Clinically significant physical findings
  • Major surgery within the last 4 weeks prior to enrollment
  • Organ allograft recipient
  • Concomitant or planned treatment which would interfere with study results
  • Any systemic medical treatment, including over the counter products and dietary supplements such as iodine, fluoride or vitamins, within one week before and during the study course
  • Known allergy against any ingredient of the study medication or meglumine
  • Participation in an investigational trial within 30 days prior to enrollment
  • Systemic intake of immunosuppressive or immunomodulatory medication or vaccination within 30 days prior to enrollment and for the whole study duration
  • Blood loss exceeding 450 mL (including blood donations) within 12 weeks prior to enrollment into the study
  • Medical history of alcohol or drug abuse or alcohol consumption greater than 21 units per week for males. A unit of alcohol is equivalent to: half a pint of average strength beer (280 mL), a glass (125 mL) of wine or a standard measure (25 mL) of spirits, sherry or port
  • A positive alcohol breath test
  • A positive urine drug screen
  • Regular smokers (more than 20 cigarettes or 5 cigars per day)
  • Presence of hepatitis B surface antigen (HBsAG), hepatitis C antibody (HCV Ab) or HIV-1 or HIV-2 antibodies at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetic Profile

Secondary Outcome Measures

Outcome Measure
Safety Profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediGene

Investigators

  • Principal Investigator: Stephen Freestone, MD, Syneos Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria

September 18, 2007

First Posted (ESTIMATE)

September 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2008

Last Update Submitted That Met QC Criteria

July 15, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CT 5001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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