HealthyPhase 1NCT00502346
A Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers
A Phase 1 study testing PM10 in people with Healthy, run by Prism Pharmaceuticals at 1 site in Canada.
Trial summary
The primary objective of the study is to compare the effect of PM101 I.V. administered as an immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives include evaluation of change from baseline in heart rate and change from baseline to the lowest value in mean arterial pressure and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PM10
- How many people
- 342 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jul 2007to 2 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a healthy male or female 18 to 55 years of age, inclusive. Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial and must have a negative serum pregnancy test at screening and upon check-in to the study facility.
- Have a BMI within the range of 18-35 kg/m2.
- Be able to communicate effectively with the study personnel.
- Have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit or on admission to the clinic.
- Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction (such as high grade AV block, bifascicular or trifascicular block), and a normal QTc interval (i.e., ≤ 450 msec for males and females).
- Be a nonsmoker defined as not having smoked in the past 6 months.
- Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication.
Who cannot join
- Known hypersensitivity or allergy to amiodarone, Captisol, Cordarone I.V. or its excipients.
- Known hypersensitivity or allergy to iodine or radio-opaque dyes.
- Women who are pregnant or breast feeding.
- A history or presence of asthma or other pulmonary disease, thyroid disease (hypo- or hyperthyroidism), hepatitis or other liver disease.
- Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
- The presence of abnormal laboratory values which are considered clinically significant.
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- Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2).
- Received an investigational drug within a period of 30 days prior to enrollment in the study.
- Received any drug therapy within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion is extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism. However, women of childbearing potential may receive hormonal contraceptives and the investigator may waive short-term use of a medication, which is not specifically prohibited, if the use occurred more than 5 half-lives prior to the first dose of any study-related treatment.
- Consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
- A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates.
- Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
- Prior participation in a Prism Pharmaceuticals amiodarone study.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
- History of severe respiratory failure, circulatory collapse, severe arterial hypotension, heart failure, cardiomyopathy, or sinus node disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers
The primary objective of the study is to compare the effect of PM101 I.V. administered as an immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives include evaluation of change from baseline in heart rate and change from baseline to the lowest value in mean arterial pressure and diastolic pressure.
- Conditions
- Healthy
- Being tested
- PM10
- Keywords
- Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM10Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study start3 Jul 2007
- Primary completion2 Nov 2007
- Study completion2 Nov 2007
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prism Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502346
- Sponsor's protocol ID
- 102
- Status last verified
- Sep 2017
- First submitted
- 10 Jul 2007
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Placebo-controlled Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00502346
- Acronym / sponsor ID
- 102
- Conditions
- Healthy
- Keywords
- Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Prism PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2007 (actual)
- Primary completion
- 2 Nov 2007 (actual)
- Study completion
- 2 Nov 2007 (actual)
- First posted
- 17 Jul 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 primary objective of the study is to compare the effect of PM101 I.V. administered as an immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives include evaluation of change from baseline in heart rate and change from baseline to the lowest value in mean arterial pressure and diastolic pressure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be a healthy male or female 18 to 55 years of age, inclusive. Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial and must have a negative serum pregnancy test at screening and upon check-in to the study facility.
- Have a BMI within the range of 18-35 kg/m2.
- Be able to communicate effectively with the study personnel.
- Have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit or on admission to the clinic.
- Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction (such as high grade AV block, bifascicular or trifascicular block), and a normal QTc interval (i.e., ≤ 450 msec for males and females).
Key exclusion criteria (15 listed)
- Known hypersensitivity or allergy to amiodarone, Captisol, Cordarone I.V. or its excipients.
- Known hypersensitivity or allergy to iodine or radio-opaque dyes.
- Women who are pregnant or breast feeding.
- A history or presence of asthma or other pulmonary disease, thyroid disease (hypo- or hyperthyroidism), hepatitis or other liver disease.
- Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
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 |
|---|---|---|
| PM10 | Drug | – |
Primary outcome
Not reported in the source record.
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 Sep 2017.
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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 PM10 in people with Healthy, run by Prism Pharmaceuticals at 1 site in Canada.
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 7 inclusion and 15 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 Sep 2017. 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 Canada. 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.
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 Sep 2017.