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| Sponsor: | Alexza Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Alexza Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00402350 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Safety, Tolerability, and Pharmacokinetics of Staccato® Fentanyl for Inhalation in Normal, Healthy Volunteers |
| 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 |
|---|---|
| 1: Experimental |
Drug: Staccato Fentanyl
Single dose
|
| 2: Experimental |
Drug: Staccato Fentanyl
2 doses
Drug: Staccato placebo
single & multiple doses
|
| 3: Experimental |
Drug: Staccato Fentanyl
4 doses
Drug: Staccato placebo
single & multiple doses
|
| 4: Experimental |
Drug: Staccato Fentanyl
6 doses
Drug: Staccato placebo
single & multiple doses
|
| 5: Experimental |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Tong J Gan, MD | Duke University |
More Information
| Responsible Party: | Alexza Pharmaceuticals, Inc ( Daniel A. Spyker, MD; Sr Director, Drug Safety & Pharmacovigilance ) |
| Study ID Numbers: | AMDC-003-101, 8 May 2006 |
| Study First Received: | November 20, 2006 |
| Last Updated: | February 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00402350 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Staccato Fentanyl, Pharmacokinetics, Pharmacodynamics |
|
Anesthetics, Intravenous Fentanyl Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |