Staccato® Loxapine for Inhalation in Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00444028
First received: March 5, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

Staccato Loxapine is being developed for the treatment of acute agitation in patients with schizophrenia. A 50 patient, dose escalation Phase I clinical trial was completed in November 2005.


Condition Intervention Phase
Schizophrenia
Drug: Loxapine thermal aerosol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato™ Loxapine for Inhalation in Normal, Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Pharmacokinetic profile
  • Dose proportionality

Estimated Enrollment: 50
Study Start Date: October 2005
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects between the ages of 18 to 55 years, inclusive.
  2. Subjects with a body mass index (BMI) ≥21 and ≤30.
  3. 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.
  4. Subjects who are willing and able to be confined to the Clinical Research Unit (CRU) for approximately 2 days and comply with the study schedule and study requirements.
  5. 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.

Exclusion Criteria:

  1. Subjects who regularly consume large amounts of xanthine-containing substances (i.e., more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day).
  2. 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).
  3. Subjects who have had an acute illness within 5 days of Visit 2 (Baseline).
  4. Subjects who have received an investigational drug within 30 days (or within 5 half lives of the investigational drug, if >30 days) prior to Visit 2 (Baseline).
  5. Subjects who have smoked tobacco within the last year.
  6. Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4.
  7. Subjects with a history of HIV positivity.
  8. Subjects with a history of allergy or intolerance to dibenzoxazepines (amoxapine and loxapine).
  9. Subjects with a known history of contraindications to anticholinergics (bowel obstructions, urinary retention, acute glaucoma).
  10. Subjects with a history of pheochromocytoma, seizure disorder, Parkinson’s disease, or Restless Leg Syndrome (RLS).
  11. Subjects who test positive for alcohol or have a positive urine drug screen at Visit 1 or Visit 2.
  12. 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).
  13. Subjects who have a clinically significant ECG abnormality.
  14. 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.
  15. Subjects who have a history of pulmonary disease that precludes administration of Staccato Loxapine (asthma, bronchitis, bronchospasm, emphysema).
  16. Subjects who have an FEV1 less than 80% of predicted values on spirometry assessments at Visit 1.
  17. Female subjects who are breastfeeding or have a positive pregnancy test at Visit 1 or Visit 2.
  18. Female participants of child-bearing potential or within 1 year of menopause, and sexually active are excluded unless they use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception include abstinence, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization, and birth control pills. Unacceptable methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.
  19. Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator’s opinion, would present undue risk to the subject, or may confound the interpretation of study results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444028

Locations
United States, Indiana
Covance Clinical Research Unit Inc., d/b/a Covance GFI Research
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
Principal Investigator: Randall Stoltz, MD West Pharmaceutical Services, GFI Research Center, Evansville, IN 47714
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00444028     History of Changes
Other Study ID Numbers: AMDC-004-101
Study First Received: March 5, 2007
Last Updated: March 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Schizophrenia, Staccato Loxapine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Loxapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014