PharmacokineticsPhase 1NCT00532012
Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®
A Phase 1 study testing RhuDex® in people with Pharmacokinetics, run by MediGene at 1 site in United Kingdom.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- RhuDex®
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charles River Clinical Services Edinburgh Ltd
Edinburgh, EH14 4AP
About this study
Official title: 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.
Read the 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.
- Conditions
- Pharmacokinetics
- Being tested
- RhuDex®
- Keywords
- Rheumatoid Arthritis, RhuDex®, Meglumine, Oral Bioavailability
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhuDex®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Profile
Secondary outcomes (1)
Safety Profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen Freestone, MD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532012
- Sponsor's protocol ID
- CT 5001
- Status last verified
- Jul 2008
- First submitted
- 18 Sep 2007
- Last updated
- 16 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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®
- ClinicalTrials.gov ID
- NCT00532012
- Acronym / sponsor ID
- CT 5001
- Conditions
- Pharmacokinetics
- Keywords
- Rheumatoid Arthritis, RhuDex®, Meglumine, Oral Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhuDex® | Drug | – |
Primary outcome
Pharmacokinetic Profile
1 secondary outcome
Safety Profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Freestone, MD principal investigator
Syneos Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RhuDex® in people with Pharmacokinetics, run by MediGene at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Profile. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2008.