Staccato® Fentanyl Pharmacokinetics in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00402350
First received: November 20, 2006
Last updated: February 3, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Breakthrough Pain
Drug: Staccato Fentanyl
Drug: Staccato placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics of Staccato® Fentanyl for Inhalation in Normal, Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To establish the plasma PK profile of fentanyl following single and multiple Staccato Fentanyl doses [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess Staccato Fentanyl absolute bioavailability and dose proportionality [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
  • Safety and Tolerability of Staccato Fentanyl [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: April 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Staccato Fentanyl
Single dose
Experimental: 2 Drug: Staccato Fentanyl
2 doses
Drug: Staccato placebo
single & multiple doses
Experimental: 3 Drug: Staccato Fentanyl
4 doses
Drug: Staccato placebo
single & multiple doses
Experimental: 4 Drug: Staccato Fentanyl
6 doses
Drug: Staccato placebo
single & multiple doses
Experimental: 5 Drug: Staccato Fentanyl
12 doses
Drug: Staccato placebo
single & multiple doses

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects between the ages of 18 to 55 years, inclusive.
  2. Subjects with a body mass index (BMI) ≥ 21 and ≤ 30.
  3. 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).
  4. 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.
  5. 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.
  6. 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:

  1. 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).
  2. 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.
  3. Subjects who have had an acute illness within 5 days of either Visit 2 or 3.
  4. 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.
  5. Subjects who have smoked tobacco within the last year.
  6. Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4.
  7. Subjects with a history of HIV positivity.
  8. Subjects with a history of allergy or intolerance to opioids.
  9. Subjects who test positive for alcohol or have a positive urine drug screen at any study visit.
  10. 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).
  11. Subjects who have a clinically significant ECG abnormality (beyond 1st degree heart block).
  12. 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.
  13. Subjects who have a history of pulmonary disease (asthma, bronchitis, bronchospasm, emphysema).
  14. Subjects who have an FEV1 less than 80% of predicted values on spirometry assessments at Visit 1.
  15. Female subjects who are breastfeeding or have a positive pregnancy test at any visit must be excluded.
  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402350

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
Principal Investigator: Tong J Gan, MD Duke University
  More Information

No publications provided

Responsible Party: Daniel A. Spyker, MD; Sr Director, Drug Safety & Pharmacovigilance, Alexza Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00402350     History of Changes
Other Study ID Numbers: AMDC-003-101, 8 May 2006
Study First Received: November 20, 2006
Last Updated: February 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato Fentanyl, Pharmacokinetics, Pharmacodynamics

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 28, 2014