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

NCT00704119 | Terminated Phase 1 DMC

• 1 other identifier: CT 5002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rhudex; pharmacokinetic study

Outcome Measures

Primary Outcomes (1)

• To assess the relationship between the dose of RhuDex® administered and the plasma concentrations achieved following single and repeated doses under fed and/or fasted conditions and with/without administration of pantoprazole

  24 -96h pharmakokinetic laboratory values

Secondary Outcomes (1)

• To gain further safety and tolerability data of RhuDex®

  during treatment phase and 28 days afterwards

Interventions

RhuDex® DRUG

* 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

Also known as: AV1142742

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects between 18 and 60 years at the time of enrolment
• Subjects who are sexually active must use adequate contraception for the duration of the study from screening until 12 weeks after the last dose.
• BMI between 18.5 and 29.9 kg/m²
• Written informed consent
• Ability to comply with the requirements of the study

You may not qualify if:

• Acute infection at time of enrolment
• History of chronic inflammation, chronic infection, other chronic disease, autoimmune disorders (e.g. diabetes mellitus) or cancer
• Clinically significant abnormal ECG
• Clinically 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 enrolment
• 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, meglumine, pantoprazole or bovine milk
• Participation in an investigational trial within 12 weeks prior to enrolment
• Systemic intake of immunosuppressive or immunomodulatory medication or vaccination within 30 days prior to enrolment and for the whole study duration
• Blood loss exceeding 450 mL (including blood donations) within 12 weeks prior to enrolment into the study.
• Medical history of alcohol or drug abuse within the last 2 years or alcohol consumption greater than 21 units per week.
• A positive alcohol breath test

Sponsors & Collaborators

• MediGene: lead

Study Sites (1)

Charles River Clinical Services Edinburgh Ltd

Edinburgh, Scotland, EH14 4AP, United Kingdom

Location

Study Officials

• Stuart Mair, MBChB, DROCG,DCPSA

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 24, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 24, 2010

Record last verified: 2010-03

Locations

GB (1)