Formulation FindingPhase 1NCT01500122
Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX®
A Phase 1 study testing RhuDex in people with Formulation Finding, run by MediGene at 1 site in United Kingdom.
Trial summary
The primary objectives of the study are: To compare the pharmacokinetic profiles of RhuDex administered as two novel oral formulations To identify the lead formulation and optimise the pharmacokinetic profile by modifying the quantitative composition of that formulation Optional: To assess the intravenous… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Formulation Finding
- What is being tested?
- RhuDex
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Jun 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males;
- Age 18-45 years;
- Body weight between 70-80 kg;
- Body Mass Index (BMI) of 18-25 kg/m2;
- Subject must agree to use an adequate method of contraception (as defined in section 9.4);
- Must provide written informed consent;
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- Non-smokers (subjects who have never smoked);
- Absence of cardiovascular risk factors at screening including 12-lead standard ECG, acceptable clinical laboratory tests and the following laboratory parameters within acceptable range: CK; LDH; GPT/GOT (ALAT/ASAT); y-GT, total vs. unconjugated/conjugated serum bilirubin; serum creatinine as judged by the Investigator
- Must be willing and able to communicate and participate in the whole study.
Who cannot join
- Participation in a clinical research study within the previous 3 months;
- Subjects who have previously been enrolled in this study;
- History of any drug or alcohol abuse in the past 2 years;
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine);
- A breath carbon monoxide reading of greater than 10 ppm at screening;
- Radiation exposure from clinical studies, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study;
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- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the Investigator (Section 20);
- Positive drugs of abuse test result (Section 20);
- Positive HBV, HCV or HIV results;
- History of cardiovascular disease,
- History of sudden death or cardiovascular death before the age of 50 in any first degree relative;
- History of clinically significant renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome;
- Any chronic infections e.g. TB
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients;
- Presence or history of allergy requiring treatment. Hayfever is allowed unless it is active;
- Donation or loss of greater than 400 mL of blood within the previous three months;
- Subjects receiving prohibited medication as described in Section 9.5;
- Subjects having received any of the following medication on a regular basis within the previous 3 months: antihypertensives such as ß-blockers, Ca-channel-inhibitors or inhibitors of the renin-angiotensin-system, statins, ASS or any other NSAIDs, diuretics, antacids/PPIs; anticoagulants, antiarrhythmics, antidepressants, antipsychotics;
- Failure to satisfy the Investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Ruddington, Nottingham, NG11 6JS
About this study
Official title: An Open-label, Non Randomized Monocentric Phase I Study Evaluation the Pharmacokinetic Profile of Novel Formulations of RHUDEX®
The primary objectives of the study are:
- To compare the pharmacokinetic profiles of RhuDex administered as two novel oral formulations
- To identify the lead formulation and optimise the pharmacokinetic profile by modifying the quantitative composition of that formulation
- Optional: To assess the intravenous pharmacokinetics of RhuDex following administration of an IV microtracer of [14C]RhuDex
- Conditions
- Formulation Finding
- Being tested
- RhuDex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhuDexDrug
Part 1:
Regimen A: Rhudex Formulation in Labrafac/ Gelucire Regimen B: Rhudex Formulation in Labrafac/ Aerosil single dose
The formulation platform (A or B) that shows the best potential to achieve the target PK profile and shows acceptable safety and tolerability will be progressed into part 2 of the study. The purpose of part 2 is to optimize the selected formulation platform. This will be achieved by administrating up to four different formulation compositions.
What is being measured
The primary outcome is the main question the study is designed to answer.
PK blood samples
All target PK evaluations will be made on the basis that the optimal plasma PK profile will be characterised by a plasma Cmax < 5000 ng/mL, an elimination half-life of > 8h and a C(last) (24h) of around 800-1000 ng/mL. Formulations will explicity not be selected based on determinations of Cmax or AUC(0-inf) alone
Measured: taken predose, 0.5 h - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8- 12- 24 -48 - 72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Formulation FindingStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500122
- Sponsor's protocol ID
- CT 5004
- Status last verified
- Jun 2012
- First submitted
- 20 Dec 2011
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non Randomized Monocentric Phase I Study Evaluation the Pharmacokinetic Profile of Novel Formulations of RHUDEX®
- ClinicalTrials.gov ID
- NCT01500122
- Acronym / sponsor ID
- CT 5004
- Conditions
- Formulation Finding
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Dec 2011 (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 primary objectives of the study are:
- To compare the pharmacokinetic profiles of RhuDex administered as two novel oral formulations
- To identify the lead formulation and optimise the pharmacokinetic profile by modifying the quantitative composition of that formulation
- Optional: To assess the intravenous pharmacokinetics of RhuDex following administration of an IV microtracer of [14C]RhuDex
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy males;
- Age 18-45 years;
- Body weight between 70-80 kg;
- Body Mass Index (BMI) of 18-25 kg/m2;
- Subject must agree to use an adequate method of contraception (as defined in section 9.4);
Key exclusion criteria (19 listed)
- Participation in a clinical research study within the previous 3 months;
- Subjects who have previously been enrolled in this study;
- History of any drug or alcohol abuse in the past 2 years;
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine);
- A breath carbon monoxide reading of greater than 10 ppm at screening;
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 |
|---|---|---|
| RhuDexPart 1: Regimen A: Rhudex Formulation in Labrafac/ Gelucire Regimen B: Rhudex Formulation in Labrafac/ Aerosil single dose The formulation platform (A or B) that shows the best potential to achieve the target PK profile and shows acceptable safety and tolerability will be progressed into part 2 of the study. The purpose of part 2 is to optimize the selected formulation platform. This will be achieved by administrating up to four different formulation compositions. | Drug | – |
Primary outcome
PK blood samples
Time frame: taken predose, 0.5 h - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8- 12- 24 -48 - 72 hours after dosing
All target PK evaluations will be made on the basis that the optimal plasma PK profile will be characterised by a plasma Cmax < 5000 ng/mL, an elimination half-life of > 8h and a C(last) (24h) of around 800-1000 ng/mL. Formulations will explicity not be selected based on determinations of Cmax or AUC(0-inf) alone
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 21 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Formulation Finding, 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 9 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: finished, as of the sponsor's last update on 21 Jun 2012. 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?
PK blood samples (time frame: taken predose, 0.5 h - 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8- 12- 24 -48 - 72 hours after dosing). 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 21 Jun 2012.