NCT00402350

Staccato Fentanyl Single and Multidose PK

Safety, Tolerability, and Pharmacokinetics of Staccato® Fentanyl for Inhalation in Normal, Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
DRUG	Inhaled Placebo	Inhaled Staccato Placebo, same number of doses as active comparator in that arm
DRUG	Inhaled Fentanyl 25 mcg	Inhaled Staccato Fentanyl, 25 mcg x 1 dose
DRUG	Intravenous Fentanyl 25 mcg	Intravenous Fentanyl 25 mcg, single dose
DRUG	Inhaled Fentanyl 25 mcg x 2	Inhaled Staccato Fentanyl, 25 mcg x 2 doses
DRUG	Inhaled Fentanyl 25 mcg x 4	Inhaled Staccato Fentanyl, 25 mcg x 4 doses
DRUG	Inhaled Fentanyl 25 mcg x 6	Inhaled Staccato Fentanyl, 25 mcg x 6 doses
DRUG	Inhaled Fentanyl 25 mcg x 12	Inhaled Staccato Fentanyl, 25 mcg x 12 doses

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-11-22
• Last updated: 2017-03-15

Locations

1 site across 1 country: United States