HealthyPhase 1LEF-2495NCT00709254
Study of Single and Multiple Doses of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Healthy Subjects
A Phase 1 study testing i.v. fentanyl and 3 mL AeroLEF (500 µg/1 mL) in people with Healthy, run by YM BioSciences at 1 site in Canada.
Trial summary
This study was designed to assess single-dose and multiple-dose PK and safety parameters utilizing a dosage of 3 mL (500 µg/mL)AeroLEF delivered via nebulization with the AeroEclipse BAN device. The study was conducted in opioid naïve subjects who were not blocked with naloxone or other opioid receptor antagonists. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- i.v. fentanyl and 3 mL AeroLEF (500 µg/1 mL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2001to Jan 2002
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking male or female with a minimum age of at least 18 years
- Body weight with aBMI range of 18.5 - 27, with a minimum weight of at least 60 kg.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, written, Informed Consent Form.
- Normal findings in the physical examination, vital signs (blood pressure between 100-140 - 60-90 mmHg, heart rate between 55-99 beats/min, respiration rate between 12-20 minute) and a 12 lead ECG.
- Negative for drug abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV.
- If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
- No clinical laboratory values outside of the Principal Investigator's acceptable range, unless the Principal Investigator decided that the subject's values are not clinically significant.
- Female subjects: (a) if pre-menopausal, have regular menstrual cycles (28-32 days), and (b) are not pregnant prior to study start and avoids pregnancy during the study and 1 month post drug administration, or (c) were surgically sterile for at least 6 months prior to enrollment, or (d) are post-menopausal for at least 1 year prior to enrollment.
Who cannot join
- Known history of hypersensitivity to fentanyl.
- Presence or history of cardiac, pulmonary, gastrointestinal, endocrine, neuromuscular, neurologic, hematological, liver or kidney disease, or any condition known to interfere with absorption, distribution , metabolism, or excretion of drugs.
- History of drug abuse or narcotic dependency.
- Use of prescription medication within 30 days preceding entry int the study, including any enzyme inducing/inhibitory drugs (excluding contraceptives).
- Participating in a clinical trial with an investigational drug within 30 days preceding this trial.
- Blood donation within 45 days preceding this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, 3-Period, Fasting, Bioavailability, Safety Assessment and PK Study Evaluating Single Dose Administration of i.v. Fentanyl (200 µg) and Single and Multiple Doses of 3 mL of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 µg/mL) Administered in Normal Healthy Subjects
This study was designed to assess single-dose and multiple-dose PK and safety parameters utilizing a dosage of 3 mL (500 µg/mL)AeroLEF delivered via nebulization with the AeroEclipse BAN device. The study was conducted in opioid naïve subjects who were not blocked with naloxone or other opioid receptor antagonists.
Read the detailed description
Period I: Subjects received an i.v.dose of fentanyl (200 µg) (Treatment A).
Period II: Subjects were randomly assigned to receive either a single-dose (Treatment B) or multi-dose (Treatment C) of AeroLEF.
In the multi-dose Treatment C group, subjects received a dose of 3 mL AeroLEF every 12 hours for a total of five doses over a 3 days with a 4 week washout period before crossing over to Period III.
Period III: Subjects from Period II participated in the crossover study and receive either a multi-dose (Treatment C, 5 doses at 12 hour intervals) or a single dose (Treatment B). Subjects in Treatment B or Treatment C were instructed to continue inhalation of AeroLEF for approximately one (1) minute beyond the point of nebulizer sputter to ensure that all aerosolized medication was delivered.
- Conditions
- Healthy
- Being tested
- i.v. fentanyl, 3 mL AeroLEF (500 µg/1 mL)
- Keywords
- AeroLEF, fentanyl, pharmacokinetics, liposome, encapsulated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i.v. fentanylDrug
Also called fetanyl citrate injection
single dose, 200 ug
3 mL AeroLEF (500 µg/1 mL)Drug
Also called Aerosolized Free and Liposome-Encapsulated Fentanyl
A single dose of 3mL (500 µg/1 mL) of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)
3 mL AeroLEF (500 µg/1 mL)Drug
Also called Aerosolized Free and Liposome-Encapsulated Fentanyl
A multiple doses of 3mL (500 µg/1 mL)of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)every 12 hours for a total of five doses over a 3 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Active comparator | Subjects received an i.v. dose of fentanyl (200 µg) Receives: Drug: i.v. fentanyl |
| Treatment Group B | Experimental | Subjects received a single dose of 3 mL AeroLEF (500 µg/1 mL) Receives: Drug: 3 mL AeroLEF (500 µg/1 mL) |
| Treatment Group C | Experimental | Subjects received multiple doses of 3 mL AeroLEF (500 µg/1 mL) every 12 hours for a total of five doses over a 3 days Receives: Drug: 3 mL AeroLEF (500 µg/1 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: continuously
Secondary outcomes (1)
pharmacokinetics and bioavailability
Measured: various time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startDec 2001
- Primary completionJan 2002
- Study completionJan 2002
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 (actual)
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Diana Pilura, PhD, Study director, YM BioSciencesPaul Y Tam, MD, FACP, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709254
- Sponsor's protocol ID
- LEF-2495
- Acronym
- LEF-2495
- Status last verified
- Jul 2008
- First submitted
- 1 Jul 2008
- Last updated
- 3 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, 3-Period, Fasting, Bioavailability, Safety Assessment and PK Study Evaluating Single Dose Administration of i.v. Fentanyl (200 µg) and Single and Multiple Doses of 3 mL of Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 µg/mL) Administered in Normal Healthy Subjects
- ClinicalTrials.gov ID
- NCT00709254
- Acronym / sponsor ID
- LEF-2495 / LEF-2495
- Conditions
- Healthy
- Keywords
- AeroLEF, fentanyl, pharmacokinetics, liposome, encapsulated
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Jan 2002 (actual)
- Study completion
- Jan 2002 (actual)
- First posted
- 3 Jul 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.
This study was designed to assess single-dose and multiple-dose PK and safety parameters utilizing a dosage of 3 mL (500 µg/mL)AeroLEF delivered via nebulization with the AeroEclipse BAN device. The study was conducted in opioid naïve subjects who were not blocked with naloxone or other opioid receptor antagonists.
Detailed description
Period I: Subjects received an i.v.dose of fentanyl (200 µg) (Treatment A).
Period II: Subjects were randomly assigned to receive either a single-dose (Treatment B) or multi-dose (Treatment C) of AeroLEF.
In the multi-dose Treatment C group, subjects received a dose of 3 mL AeroLEF every 12 hours for a total of five doses over a 3 days with a 4 week washout period before crossing over to Period III.
Period III: Subjects from Period II participated in the crossover study and receive either a multi-dose (Treatment C, 5 doses at 12 hour intervals) or a single dose (Treatment B). Subjects in Treatment B or Treatment C were instructed to continue inhalation of AeroLEF for approximately one (1) minute beyond the point of nebulizer sputter to ensure that all aerosolized medication was delivered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Active comparator | Drug: i.v. fentanylSubjects received an i.v. dose of fentanyl (200 µg) |
| Treatment Group B | Experimental | Drug: 3 mL AeroLEF (500 µg/1 mL)Subjects received a single dose of 3 mL AeroLEF (500 µg/1 mL) |
| Treatment Group C | Experimental | Drug: 3 mL AeroLEF (500 µg/1 mL)Subjects received multiple doses of 3 mL AeroLEF (500 µg/1 mL) every 12 hours for a total of five doses over a 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Non-smoking male or female with a minimum age of at least 18 years
- Body weight with aBMI range of 18.5 - 27, with a minimum weight of at least 60 kg.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, written, Informed Consent Form.
- Normal findings in the physical examination, vital signs (blood pressure between 100-140 - 60-90 mmHg, heart rate between 55-99 beats/min, respiration rate between 12-20 minute) and a 12 lead ECG.
- Negative for drug abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV.
Key exclusion criteria (6 listed)
- Known history of hypersensitivity to fentanyl.
- Presence or history of cardiac, pulmonary, gastrointestinal, endocrine, neuromuscular, neurologic, hematological, liver or kidney disease, or any condition known to interfere with absorption, distribution , metabolism, or excretion of drugs.
- History of drug abuse or narcotic dependency.
- Use of prescription medication within 30 days preceding entry int the study, including any enzyme inducing/inhibitory drugs (excluding contraceptives).
- Participating in a clinical trial with an investigational drug within 30 days preceding this 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 |
|---|---|---|
| i.v. fentanylAlso: fetanyl citrate injectionsingle dose, 200 ug | Drug | Treatment Group A |
| 3 mL AeroLEF (500 µg/1 mL)Also: Aerosolized Free and Liposome-Encapsulated FentanylA single dose of 3mL (500 µg/1 mL) of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl) | Drug | Treatment Group B |
| 3 mL AeroLEF (500 µg/1 mL)Also: Aerosolized Free and Liposome-Encapsulated FentanylA multiple doses of 3mL (500 µg/1 mL)of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)every 12 hours for a total of five doses over a 3 days | Drug | Treatment Group C |
Primary outcome
Adverse Events
Time frame: continuously
1 secondary outcome
pharmacokinetics and bioavailability
Time frame: various time points
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 3 Jul 2008.
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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.
Diana Pilura, PhD study director
YM BioSciences
Paul Y Tam, MD, FACP principal investigator
University of Toronto
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 i.v. fentanyl and 3 mL AeroLEF (500 µg/1 mL) in people with Healthy, run by YM BioSciences 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 8 inclusion and 6 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 3 Jul 2008. 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.
What does the primary outcome measure?
Adverse Events (time frame: continuously). 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 3 Jul 2008.