- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00402350
Staccato Fentanyl Single and Multidose PK
March 13, 2017 updated by: Alexza Pharmaceuticals, Inc.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Subjects (2) from each of the 4 dose escalation arms
|
Inhaled Staccato Placebo, same number of doses as active comparator in that arm
|
Experimental: 25 mcg IV and Inhaled Crossover
Single dose crossover (IV vs Inhaled)
|
Inhaled Staccato Fentanyl, 25 mcg x 1 dose
Intravenous Fentanyl 25 mcg, single dose
|
Experimental: Inhaled fentanyl 25 mcg x 2
Inhaled Staccato fentanyl, 25 mcg x 2
|
Inhaled Staccato Fentanyl, 25 mcg x 2 doses
|
Experimental: Inhaled fentanyl 25 mcg x 4
Inhaled Staccato fentanyl, 25 mcg x 4
|
Inhaled Staccato Fentanyl, 25 mcg x 4 doses
|
Experimental: Inhaled fentanyl 25 mcg x 6
Inhaled Staccato fentanyl, 25 mcg x 6
|
Inhaled Staccato Fentanyl, 25 mcg x 6 doses
|
Experimental: Inhaled fentanyl 25 mcg x 12
Inhaled Staccato fentanyl, 25 mcg x 12
|
Inhaled Staccato Fentanyl, 25 mcg x 12 doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish the plasma PK profile of fentanyl following single and multiple Staccato Fentanyl doses
Time Frame: 8 hours
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess Staccato Fentanyl absolute bioavailability and dose proportionality
Time Frame: 8 hours
|
8 hours
|
Safety and Tolerability of Staccato Fentanyl
Time Frame: 8 hours
|
8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tong J Gan, MD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
November 20, 2006
First Submitted That Met QC Criteria
November 21, 2006
First Posted (Estimate)
November 22, 2006
Study Record Updates
Last Update Posted (Actual)
March 15, 2017
Last Update Submitted That Met QC Criteria
March 13, 2017
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMDC-003-101
- 8 May 2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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