Status:
TERMINATED
Study Evaluating the Pharmacokinetic Profile of RhuDex® in a Tablet Formulation
Lead Sponsor:
MediGene
Conditions:
Pharmacokinetics
Eligibility:
MALE
18-60 years
Phase:
PHASE1
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 surfac...
Detailed Description
This is an open-label, non-randomized, monocentric Phase I study to evaluate the pharmacokinetic profile of single-dosed and repeat-dosed RhuDex® using a tablet formulation as well as to assess the ef...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- A positive urine drug screen
- Smokers who smoke \> 5 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
- Subject whose partner is pregnant or lactating
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00704119
Start Date
May 1 2008
End Date
August 1 2008
Last Update
March 24 2010
Active Locations (1)
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1
Charles River Clinical Services Edinburgh Ltd
Edinburgh, Scotland, United Kingdom, EH14 4AP