Breakthrough PainPhase 1NCT00402350
Staccato Fentanyl Single and Multidose PK
A Phase 1 study testing Inhaled Fentanyl 25 mcg, Intravenous Fentanyl 25 mcg and Inhaled Fentanyl 25 mcg x 2 in people with Breakthrough Pain, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Breakthrough Pain
- What is being tested?
- Inhaled Fentanyl 25 mcg, Intravenous Fentanyl 25 mcg and Inhaled Fentanyl 25 mcg x 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2006
- 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
- Male and female subjects between the ages of 18 to 55 years, inclusive.
- Subjects with a body mass index (BMI) ≥ 21 and ≤ 30.
- Female subjects who are not pregnant, or are surgically sterile or 2 years postmenopausal. If of childbearing potential, she must be using a medically-accepted method of birth control and agree to continue use of this method for at least 30 days after the study (i.e., barrier method with spermicide, steroidal contraceptive [oral, transdermal, and implanted, including Depo-Provera; contraceptives must be used in conjunction with a barrier method], or intrauterine device).
- Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures.
- Subjects who are willing and able to be confined to the Clinical Research Unit (CRU) for approximately 10 hours and comply with the study schedule and study requirements.
- Subjects who are in good general health as determined by a complete medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, and urinalysis.
Who cannot join
- Subjects who regularly consume large amounts of xanthine-containing substances (i.e., more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day).
- Subjects who have taken prescription or nonprescription medication (with the exception of vitamins, acetaminophen, and steroidal contraceptives for women of child-bearing potential if medically necessary) within 5 days of Visits 2 or 3.
- Subjects who have had an acute illness within 5 days of either Visit 2 or 3.
- Subjects who have received an investigational drug within 30 days (or within 5 half lives of the investigational drug) prior to Visit 2 or 3.
- Subjects who have smoked tobacco within the last year.
- Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4.
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- Subjects with a history of HIV positivity.
- Subjects with a history of allergy or intolerance to opioids.
- Subjects who test positive for alcohol or have a positive urine drug screen at any study visit.
- Subjects who have hypotension (systolic blood pressure ≤90 mmHg, diastolic blood pressure ≤50 mmHg), or hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg).
- Subjects who have a clinically significant ECG abnormality (beyond 1st degree heart block).
- Subjects with a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), stroke, transient ischemic attack (TIA), or a significant neurological disorder.
- Subjects who have a history of pulmonary disease (asthma, bronchitis, bronchospasm, emphysema).
- Subjects who have an FEV1 less than 80% of predicted values on spirometry assessments at Visit 1.
- Female subjects who are breastfeeding or have a positive pregnancy test at any visit must be excluded.
- Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Staccato® Fentanyl for Inhalation in Normal, Healthy Volunteers
The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl, evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.
- Conditions
- Breakthrough Pain
- Being tested
- Inhaled Placebo, Inhaled Fentanyl 25 mcg, Intravenous Fentanyl 25 mcg, Inhaled Fentanyl 25 mcg x 2, Inhaled Fentanyl 25 mcg x 4
- Keywords
- Staccato Fentanyl, Pharmacokinetics, Pharmacodynamics, inhaled fentanyl
- Medical subject headings
- Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled PlaceboDrug
Inhaled Staccato Placebo, same number of doses as active comparator in that arm
Inhaled Fentanyl 25 mcgDrug
Inhaled Staccato Fentanyl, 25 mcg x 1 dose
Intravenous Fentanyl 25 mcgDrug
Intravenous Fentanyl 25 mcg, single dose
Inhaled Fentanyl 25 mcg x 2Drug
Inhaled Staccato Fentanyl, 25 mcg x 2 doses
Inhaled Fentanyl 25 mcg x 4Drug
Inhaled Staccato Fentanyl, 25 mcg x 4 doses
Inhaled Fentanyl 25 mcg x 6Drug
Inhaled Staccato Fentanyl, 25 mcg x 6 doses
Inhaled Fentanyl 25 mcg x 12Drug
Inhaled Staccato Fentanyl, 25 mcg x 12 doses
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects (2) from each of the 4 dose escalation arms Receives: Drug: Inhaled Placebo |
| 25 mcg IV and Inhaled Crossover | Experimental | Single dose crossover (IV vs Inhaled) Receives: Drug: Inhaled Fentanyl 25 mcg; Drug: Intravenous Fentanyl 25 mcg |
| Inhaled fentanyl 25 mcg x 2 | Experimental | Inhaled Staccato fentanyl, 25 mcg x 2 Receives: Drug: Inhaled Fentanyl 25 mcg x 2 |
| Inhaled fentanyl 25 mcg x 4 | Experimental | Inhaled Staccato fentanyl, 25 mcg x 4 Receives: Drug: Inhaled Fentanyl 25 mcg x 4 |
| Inhaled fentanyl 25 mcg x 6 | Experimental | Inhaled Staccato fentanyl, 25 mcg x 6 Receives: Drug: Inhaled Fentanyl 25 mcg x 6 |
| Inhaled fentanyl 25 mcg x 12 | Experimental | Inhaled Staccato fentanyl, 25 mcg x 12 Receives: Drug: Inhaled Fentanyl 25 mcg x 12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the plasma PK profile of fentanyl following single and multiple Staccato Fentanyl doses
Measured: 8 hours
Secondary outcomes (2)
To assess Staccato Fentanyl absolute bioavailability and dose proportionality
Measured: 8 hours
Safety and Tolerability of Staccato Fentanyl
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startApr 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breakthrough PainStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Tong J Gan, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402350
- Sponsor's protocol ID
- AMDC-003-101
- Other IDs
- 8 May 2006
- Status last verified
- Feb 2008
- First submitted
- 20 Nov 2006
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Macleod DB, Habib AS, Ikeda K, Spyker DA, Cassella JV, Ho KY, Gan TJ. Inhaled fentanyl aerosol in healthy volunteers: pharmacokinetics and pharmacodynamics. Anesth Analg. 2012 Nov;115(5):1071-7. doi: 10.1213/ANE.0b013e3182691898. Epub 2012 Sep 13.
PubMed 22984155
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Staccato® Fentanyl for Inhalation in Normal, Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00402350
- Acronym / sponsor ID
- AMDC-003-101
- Conditions
- Breakthrough Pain
- Keywords
- Staccato Fentanyl, Pharmacokinetics, Pharmacodynamics, inhaled fentanyl
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Apr 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Nov 2006 (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 Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl, evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Inhaled PlaceboSubjects (2) from each of the 4 dose escalation arms |
| 25 mcg IV and Inhaled Crossover | Experimental | Drug: Inhaled Fentanyl 25 mcg, Drug: Intravenous Fentanyl 25 mcgSingle dose crossover (IV vs Inhaled) |
| Inhaled fentanyl 25 mcg x 2 | Experimental | Drug: Inhaled Fentanyl 25 mcg x 2Inhaled Staccato fentanyl, 25 mcg x 2 |
| Inhaled fentanyl 25 mcg x 4 | Experimental | Drug: Inhaled Fentanyl 25 mcg x 4Inhaled Staccato fentanyl, 25 mcg x 4 |
| Inhaled fentanyl 25 mcg x 6 | Experimental | Drug: Inhaled Fentanyl 25 mcg x 6Inhaled Staccato fentanyl, 25 mcg x 6 |
| Inhaled fentanyl 25 mcg x 12 | Experimental | Drug: Inhaled Fentanyl 25 mcg x 12Inhaled Staccato fentanyl, 25 mcg x 12 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female subjects between the ages of 18 to 55 years, inclusive.
- Subjects with a body mass index (BMI) ≥ 21 and ≤ 30.
- Female subjects who are not pregnant, or are surgically sterile or 2 years postmenopausal. If of childbearing potential, she must be using a medically-accepted method of birth control and agree to continue use of this method for at least 30 days after the study (i.e., barrier method with spermicide, steroidal contraceptive [oral, transdermal, and implanted, including Depo-Provera; contraceptives must be used in conjunction with a barrier method], or intrauterine device).
- Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures.
- Subjects who are willing and able to be confined to the Clinical Research Unit (CRU) for approximately 10 hours and comply with the study schedule and study requirements.
Key exclusion criteria (16 listed)
- Subjects who regularly consume large amounts of xanthine-containing substances (i.e., more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day).
- Subjects who have taken prescription or nonprescription medication (with the exception of vitamins, acetaminophen, and steroidal contraceptives for women of child-bearing potential if medically necessary) within 5 days of Visits 2 or 3.
- Subjects who have had an acute illness within 5 days of either Visit 2 or 3.
- Subjects who have received an investigational drug within 30 days (or within 5 half lives of the investigational drug) prior to Visit 2 or 3.
- Subjects who have smoked tobacco within the last year.
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 |
|---|---|---|
| Inhaled PlaceboInhaled Staccato Placebo, same number of doses as active comparator in that arm | Drug | Placebo |
| Inhaled Fentanyl 25 mcgInhaled Staccato Fentanyl, 25 mcg x 1 dose | Drug | 25 mcg IV and Inhaled Crossover |
| Intravenous Fentanyl 25 mcgIntravenous Fentanyl 25 mcg, single dose | Drug | 25 mcg IV and Inhaled Crossover |
| Inhaled Fentanyl 25 mcg x 2Inhaled Staccato Fentanyl, 25 mcg x 2 doses | Drug | Inhaled fentanyl 25 mcg x 2 |
| Inhaled Fentanyl 25 mcg x 4Inhaled Staccato Fentanyl, 25 mcg x 4 doses | Drug | Inhaled fentanyl 25 mcg x 4 |
| Inhaled Fentanyl 25 mcg x 6Inhaled Staccato Fentanyl, 25 mcg x 6 doses | Drug | Inhaled fentanyl 25 mcg x 6 |
| Inhaled Fentanyl 25 mcg x 12Inhaled Staccato Fentanyl, 25 mcg x 12 doses | Drug | Inhaled fentanyl 25 mcg x 12 |
Primary outcome
To establish the plasma PK profile of fentanyl following single and multiple Staccato Fentanyl doses
Time frame: 8 hours
2 secondary outcomes
To assess Staccato Fentanyl absolute bioavailability and dose proportionality
Time frame: 8 hours
Safety and Tolerability of Staccato Fentanyl
Time frame: 8 hours
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 15 Mar 2017.
- Background: PubMed 22984155Macleod DB, Habib AS, Ikeda K, Spyker DA, Cassella JV, Ho KY, Gan TJ. Inhaled fentanyl aerosol in healthy volunteers: pharmacokinetics and pharmacodynamics. Anesth Analg. 2012 Nov;115(5):1071-7. doi: 10.1213/ANE.0b013e3182691898. Epub 2012 Sep 13.
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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.
Tong J Gan, MD principal investigator
Duke University
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 Inhaled Fentanyl 25 mcg, Intravenous Fentanyl 25 mcg and Inhaled Fentanyl 25 mcg x 2 in people with Breakthrough Pain, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
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 6 inclusion and 16 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 15 Mar 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 United States. 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. Some participants in this study may receive a placebo. 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?
To establish the plasma PK profile of fentanyl following single and multiple Staccato Fentanyl doses (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402350, which also lists 1 linked publication.
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 15 Mar 2017.