Staccato Loxapine Pulmonary Safety in Healthy Volunteers

NCT00789360 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: AMDC-004-10412 September 2008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry

  The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,

  17 post-treatment time points (15 min to 32 hr)

Secondary Outcomes (1)

• The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry

  17 post-treatment time points (15 min to 32 hr)

Study Arms (2)

Inhaled Placebo crossed over to Inhaled Loxapine

EXPERIMENTAL

Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart

Drug: Inhaled Placebo; Drug: Inhaled Loxapine

Inhaled Loxapine crossed over to Inhaled Placebo

EXPERIMENTAL

Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;

Drug: Inhaled Placebo; Drug: Inhaled Loxapine

Interventions

Inhaled Placebo DRUG

Inhaled Staccato Placebo, 2 inhalations, 8 hours apart

Inhaled Loxapine crossed over to Inhaled Placebo; Inhaled Placebo crossed over to Inhaled Loxapine

Inhaled Loxapine DRUG

Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart

Inhaled Loxapine crossed over to Inhaled Placebo; Inhaled Placebo crossed over to Inhaled Loxapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nonsmoker subjects in good general health with normal spirometry at screening AND baseline

You may not qualify if:

• history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead

Study Sites (1)

Northeast Medical Research

North Dartmouth, Massachusetts, 02747, United States

Location

Results Point of Contact

• Title: Executive VP, Research & Development, Regulatory & Quality
• Organization: Alexza Pharmaceuticals, Inc

ClinicalTrialsInfo@alexza.com

650.944.7071

Study Officials

• David S. Miller, MD

  Northeast Medical Research, North Dartmouth, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 11, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 11, 2019
• Results First Posted: March 11, 2019

Record last verified: 2009-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)