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Staccato Fentanyl Single and Multidose PK

NCT00402350 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-03-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Tong J Gan, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00402350 on ClinicalTrials.gov