HealthyPhase 1NCT01320410
Pharmacokinetics, Safety, and Tolerance Study of Single Dose Administration of Risperidone ISM®
A Phase 1 study testing ISM® in people with Healthy, run by Rovi Pharmaceuticals Laboratories.
Trial summary
The study will comprise two dosing periods in two different cohorts of healthy volunteers. The investigators will begin with a single dosage period I (1 injection of 25 mg of Risperidone for each subject); single dosage period II, different from the previous one (1 injection of 37.5 mg of Risperidone for each… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ISM®
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers of both sexes with a minimum age of 18 years and a maximum age of 50 years.
- Healthy female volunteers should have a negative pregnancy test and, if they are of childbearing age, should use at least 2 medically accepted contraceptive methods.
- Each volunteer must be capable of understanding enough to complete all tests and exams required in the protocol.
- Each volunteer must understand the nature of the study and sign an informed consent document.
- Vital signs (systolic and diastolic blood pressure, heart rate, and temperature) and ECG record within the normal range.
- The results of the laboratory tests (complete blood count and biochemistry) and ECG should fall within the normal reference ranges or show minor deviations that the investigator does not consider clinically relevant.
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- The investigator must consider the volunteers suitable candidates for prolonged release intramuscular administration.
- Healthy volunteers must have a body mass index between 19 and 27 kg/m2, and weigh between 50 and 100 kg.
- Healthy volunteers may not have known cardiovascular disease, orthostatic hypotension, seizures, a family history of prolonged QT interval, bradycardia, electrolyte disturbances (hypokalemia, hypomagnesemia), or hyperprolactinemia.
Who cannot join
- Pregnant women, nursing women, and female volunteers who are not using effective contraceptive methods.
- Previous history of alcohol, drug, or substance abuse during the month prior to the selection. Average daily alcohol consumption exceeding 2 units (20 g/d). Smokers of more than 5-10 cigarettes per day in the 3 months prior to the start of the study.
- History of allergy, idiosyncrasy, hypersensitivity or severe adverse reactions to medications, or contraindications to treatment with Risperidone as recorded in the data sheet of the drug.
- Positive serology for hepatitis B or C, or for HIV.
- History or clinical evidence of cardiovascular disease, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, psychiatric, or other chronic diseases that may interfere with the objectives of the trial.
- Major consumer of stimulating beverages (> 5 cups of coffee, tea, cola drinks, or similar per day).
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- Positive urine test for ethanol, cannabis, cocaine, amphetamines, benzodiazepines, or opiates.
- Baseline platelet number below 100,000/mm3 or serum potassium> 5.5 mEq / L.
- Having undergone surgery in the past 6 months.
- Plasma prolactin values outside the reference range (40 mcIU/ml to 530 mcIU/ml).
- Having participated in another clinical trial during the three months before the start of the study.
- Having donated blood within 4 weeks before the start of the study.
- Having taken medication regularly in the month prior to the start of the study or symptomatic medication in the week before the start of the study, except for oral contraceptives, vitamins, herbal remedies, or dietary supplements that, according to the Principal Investigator or co-workers designated by him/her, do not involve a risk for the subjects and do not interfere with the objectives of the study.
- Taking ASA and/or NSAIDs within 10 days before the start of the trial until the end of the study
About this study
Official title: Clinical Trial to Evaluate the Pharmacokinetics, Safety, and Tolerance of Single Dose Administration of a New Injectable Prolonged Release Formulation of Risperidone Using ISM® Technology in Healthy Volunteers
The study will comprise two dosing periods in two different cohorts of healthy volunteers. The investigators will begin with a single dosage period I (1 injection of 25 mg of Risperidone for each subject); single dosage period II, different from the previous one (1 injection of 37.5 mg of Risperidone for each subject), in a second group of healthy volunteers different from the first group will not start until after a preliminary analysis has been made of the safety data and plasma concentration data are known for the formulation of prolonged release Risperidone using the ISM® technology.
- Conditions
- Healthy
- Being tested
- ISM®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISM®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to evaluate the pharmacokinetics, safety, and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
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
- Non-randomised
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320410
- Sponsor's protocol ID
- ROV-RISP-2009-01
- Status last verified
- Mar 2011
- First submitted
- 17 Mar 2011
- Last updated
- 1 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Pharmacokinetics, Safety, and Tolerance of Single Dose Administration of a New Injectable Prolonged Release Formulation of Risperidone Using ISM® Technology in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01320410
- Acronym / sponsor ID
- ROV-RISP-2009-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- First posted
- 22 Mar 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 study will comprise two dosing periods in two different cohorts of healthy volunteers. The investigators will begin with a single dosage period I (1 injection of 25 mg of Risperidone for each subject); single dosage period II, different from the previous one (1 injection of 37.5 mg of Risperidone for each subject), in a second group of healthy volunteers different from the first group will not start until after a preliminary analysis has been made of the safety data and plasma concentration data are known for the formulation of prolonged release Risperidone using the ISM® technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy volunteers of both sexes with a minimum age of 18 years and a maximum age of 50 years.
- Healthy female volunteers should have a negative pregnancy test and, if they are of childbearing age, should use at least 2 medically accepted contraceptive methods.
- Each volunteer must be capable of understanding enough to complete all tests and exams required in the protocol.
- Each volunteer must understand the nature of the study and sign an informed consent document.
- Vital signs (systolic and diastolic blood pressure, heart rate, and temperature) and ECG record within the normal range.
Key exclusion criteria (14 listed)
- Pregnant women, nursing women, and female volunteers who are not using effective contraceptive methods.
- Previous history of alcohol, drug, or substance abuse during the month prior to the selection. Average daily alcohol consumption exceeding 2 units (20 g/d). Smokers of more than 5-10 cigarettes per day in the 3 months prior to the start of the study.
- History of allergy, idiosyncrasy, hypersensitivity or severe adverse reactions to medications, or contraindications to treatment with Risperidone as recorded in the data sheet of the drug.
- Positive serology for hepatitis B or C, or for HIV.
- History or clinical evidence of cardiovascular disease, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, psychiatric, or other chronic diseases that may interfere with the objectives of the trial.
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 |
|---|---|---|
| ISM® | Drug | – |
Primary outcome
The main objective of the study is to evaluate the pharmacokinetics, safety, and tolerability
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 1 May 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ISM® in people with Healthy, run by Rovi Pharmaceuticals Laboratories.
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 14 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 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The main objective of the study is to evaluate the pharmacokinetics, safety, and tolerability. 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 1 May 2014.