HealthyPhase 1NCT00629733
Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers
A Phase 1 study testing RO-14 in people with Healthy, run by Rovi Pharmaceuticals Laboratories at 1 site in Spain.
Trial summary
Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers 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
- Healthy
- What is being tested?
- RO-14
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2007to Dec 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers: male subjects aged between 18 and 45 years
- Body weight: 65-75 Kg
- Not meaningful abnormalities in physical examination and in clinical history
- Without evidence of significant organic or psychiatric illness
- Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
- Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
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- Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
- Not give blood in the last 4 weeks.
- Healthy male volunteers who have not received heparin in the past
- Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent
Who cannot join
- Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
- Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day
- Allergy, idiosyncrasy or hypersensitivity to medicines
- Healthy volunteers who are receiving another medication in the past 15 days
- Positive serology of hepatitis B, C or HIV
- Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
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- Mayor Surgery in the last 6 months
- Smoking > 10 cigarettes / day
- Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine
- Healthy volunteers with a familiar history evident hemorrhagic episodes
Trial locations and contacts
1 site in 1 country.
About this study
Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers
- Conditions
- Healthy
- Being tested
- RO-14
- Keywords
- pharmacokinetics, ultra low molecular weight heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO-14Drug
| Study group | Role | What they receive |
|---|---|---|
| Ro-14 | Experimental | Not described Receives: Drug: RO-14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers
Measured: safety parameters
Secondary outcomes (1)
Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses.
Measured: anti-Xa activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Manuel Barbanoj, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629733
- Sponsor's protocol ID
- ROV-RO14-2006-01
- Status last verified
- Jun 2011
- First submitted
- 15 Feb 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00629733
- Acronym / sponsor ID
- ROV-RO14-2006-01
- Conditions
- Healthy
- Keywords
- pharmacokinetics, ultra low molecular weight heparin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Mar 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.
Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ro-14 | Experimental | Drug: RO-14 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy volunteers: male subjects aged between 18 and 45 years
- Body weight: 65-75 Kg
- Not meaningful abnormalities in physical examination and in clinical history
- Without evidence of significant organic or psychiatric illness
- Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
Key exclusion criteria (10 listed)
- Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
- Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day
- Allergy, idiosyncrasy or hypersensitivity to medicines
- Healthy volunteers who are receiving another medication in the past 15 days
- Positive serology of hepatitis B, C or HIV
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 |
|---|---|---|
| RO-14 | Drug | Ro-14 |
Primary outcome
Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers
Time frame: safety parameters
1 secondary outcome
Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses.
Time frame: anti-Xa activity
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 8 Jun 2011.
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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.
Dr Manuel Barbanoj principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 RO-14 in people with Healthy, run by Rovi Pharmaceuticals Laboratories at 1 site in Spain.
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 10 inclusion and 10 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 8 Jun 2011. 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 Spain. 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?
Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers (time frame: safety parameters). 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 8 Jun 2011.