PharmacokineticsPhase 1NCT00704119
Study Evaluating the Pharmacokinetic Profile of RhuDex® in a Tablet Formulation
A Phase 1 study testing RhuDex® in people with Pharmacokinetics, run by MediGene at 1 site in United Kingdom.
Trial 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… 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
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to Aug 2008
- 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 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
Who cannot join
- 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
Show all 19Show 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, 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charles River Clinical Services Edinburgh Ltd
Edinburgh, Scotland, EH14 4AP
About this study
Official title: CT 5002 An Open-label, Non-randomized, Monocentric Phase I Study Evaluating the Pharmacokinetic Profile of RhuDex® Using 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) 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.
Read the 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 effect of food and the effect with co-administration of a proton pump inhibitor on the bioavailability of RhuDex®.
12 healthy male subjects will receive study medication in 8 different treatment periods in 4 subsequent steps A, B, C and D.
Within steps A and B, the subjects will receive different treatments (4 in A and 2 in B), sequentially. There will be a wash-out period of at least 4 days between each of the 8 different treatments/treatment periods of steps A, B, C and D.
In Step A, each subject will receive increasing doses of RhuDex® in 4 subsequent treatments. In Step B, each subject will receive 2 different doses of RhuDex® preceded by pantoprazole intake, in 2 subsequent treatments, and in Step C the RhuDex® dosing will be preceded by a standardized high-fat, high-calorie meal. In Step D, RhuDex® will be administered twice daily for 7 days.
For assessing the pharmacokinetic profile of RhuDex® in steps A, B and C, blood samples will be collected prior to and at different intervals after RhuDex® administration. In step D, blood samples will be collected on Days 1, 2, 4 and 7. Cmin, Cmax, tmax, t½ term, CL/F, AUC(0-t), and AUC(0-∞) of RhuDex® will be analyzed.
Safety will be evaluated by regular observation and documentation of AEs, vital signs, physical examination, ECG, and laboratory parameters.
- Conditions
- Pharmacokinetics
- Being tested
- RhuDex®
- Keywords
- Rhudex, pharmacokinetic study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhuDex®Drug
Also called AV1142742
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 -96h pharmakokinetic laboratory values
Secondary outcomes (1)
To gain further safety and tolerability data of RhuDex®
Measured: during treatment phase and 28 days afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionAug 2008
Why it stopped: Following an SAE, study was put on hold. After performing preclinical follow-up studies, volunteers were no longer available for continuation.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stuart Mair, MBChB, DROCG,DCPSA, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704119
- Sponsor's protocol ID
- CT 5002
- Status last verified
- Mar 2010
- First submitted
- 23 Jun 2008
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT 5002 An Open-label, Non-randomized, Monocentric Phase I Study Evaluating the Pharmacokinetic Profile of RhuDex® Using a Tablet Formulation
- ClinicalTrials.gov ID
- NCT00704119
- Acronym / sponsor ID
- CT 5002
- Conditions
- Pharmacokinetics
- Keywords
- Rhudex, pharmacokinetic study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following an SAE, study was put on hold. After performing preclinical follow-up studies, volunteers were no longer available for continuation.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Jun 2008 (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.
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.
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 effect of food and the effect with co-administration of a proton pump inhibitor on the bioavailability of RhuDex®.
12 healthy male subjects will receive study medication in 8 different treatment periods in 4 subsequent steps A, B, C and D.
Within steps A and B, the subjects will receive different treatments (4 in A and 2 in B), sequentially. There will be a wash-out period of at least 4 days between each of the 8 different treatments/treatment periods of steps A, B, C and D.
In Step A, each subject will receive increasing doses of RhuDex® in 4 subsequent treatments. In Step B, each subject will receive 2 different doses of RhuDex® preceded by pantoprazole intake, in 2 subsequent treatments, and in Step C the RhuDex® dosing will be preceded by a standardized high-fat, high-calorie meal. In Step D, RhuDex® will be administered twice daily for 7 days.
For assessing the pharmacokinetic profile of RhuDex® in steps A, B and C, blood samples will be collected prior to and at different intervals after RhuDex® administration. In step D, blood samples will be collected on Days 1, 2, 4 and 7. Cmin, Cmax, tmax, t½ term, CL/F, AUC(0-t), and AUC(0-∞) of RhuDex® will be analyzed.
Safety will be evaluated by regular observation and documentation of AEs, vital signs, physical examination, ECG, and laboratory parameters.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 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
Key exclusion criteria (19 listed)
- 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
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®Also: AV1142742* 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 | Drug | – |
Primary outcome
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
Time frame: 24 -96h pharmakokinetic laboratory values
1 secondary outcome
To gain further safety and tolerability data of RhuDex®
Time frame: during treatment phase and 28 days afterwards
Results and safety
The study was stopped early (reason given: Following an SAE, study was put on hold. After performing preclinical follow-up studies, volunteers were no longer available for continuation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
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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.
Stuart Mair, MBChB, DROCG,DCPSA 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 19 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: stopped early, as of the sponsor's last update on 24 Mar 2010. 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 was stopped early (reason given: Following an SAE, study was put on hold. After performing preclinical follow-up studies, volunteers were no longer available for continuation.). Results are not available in the source record.
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?
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 (time frame: 24 -96h pharmakokinetic laboratory values). 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 24 Mar 2010.