Staccato Alprazolam Single Dose PK

NCT00444522 | Completed Phase 1 FDA Drug

• 1 other identifier: AMDC-002-101
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

We are developing Staccato Alprazolam for the acute treatment of panic attacks associated with panic disorder.

Conditions

Healthy

Keywords

Panic attacks, Staccato® Alprazolam

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile and dose proportionality

Interventions

Alprazolam thermal aerosol DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects between the ages of 18 to 55 years, inclusive.
• Subjects with a body mass index (BMI) ≥21 and ≤30.
• 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.
• Subjects who are willing and able to be confined to the Clinical Research Unit (CRU) and comply with the study schedule and study requirements.
• 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.

You may not qualify if:

• Subjects who regularly consume large amounts of xanthine-containing substances (ie, more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day).
• Subjects who have taken prescription or nonprescription medication (with the exception of vitamins and acetaminophen if medically necessary) within 5 days of Visit 2 (Baseline).
• Subjects who have had an acute illness within 5 days of Visit 2 (Baseline).
• Subjects who have received an investigational drug within 30 days (or within 5 half lives investigational drug, if \>30 days) prior to Visit 2 (Baseline).
• Subjects who have smoked tobacco within the last year.
• Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4.
• Subjects with a history of HIV positivity.
• Subjects with a history of allergy or intolerance to benzodiazepines or related drugs (alprazolam, lorazepam, diazepam, etizolam, clonazepam, adinazolam).
• Subjects who test positive for alcohol or have a positive urine drug screen at Visit 1 or Visit 2.
• 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).
• Subjects who have a clinically significant ECG abnormality.
• Subjects with a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), stroke, transient ischemic attack (TIA), or a neurological disorder.
• Subjects who have a history of pulmonary disease that precludes administration of Staccato Alprazolam (asthma, bronchitis, bronchospasm, emphysema).
• Subjects who have an FEV1 less than 80% of predicted values on spirometry assessments at Visit 1.
• Female subjects who are breastfeeding or have a positive pregnancy test at Visit 1 or Visit 2.

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Randall Stoltz, MD

  West Pharmaceutical Services, GFI Research Center, Evansville, IN 47714

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 8, 2007
• Study Start: June 1, 2005
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: March 14, 2017

Record last verified: 2007-03

Data Sharing

• IPD Sharing: Will share