Staccato® Loxapine for Inhalation in Schizophrenia
This study has been completed.
Information provided by:
Alexza Pharmaceuticals, Inc.
First received: March 5, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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.
Drug: Loxapine thermal aerosol
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato™ Loxapine for Inhalation in Normal, Healthy Volunteers
Primary Outcome Measures:
- Pharmacokinetic profile
- Dose proportionality
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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) for approximately 2 days 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.
- 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).
- 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 of the 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 dibenzoxazepines (amoxapine and loxapine).
- Subjects with a known history of contraindications to anticholinergics (bowel obstructions, urinary retention, acute glaucoma).
- Subjects with a history of pheochromocytoma, seizure disorder, Parkinson’s disease, or Restless Leg Syndrome (RLS).
- 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 Loxapine (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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444028
|Covance Clinical Research Unit Inc., d/b/a Covance GFI Research
|Evansville, Indiana, United States, 47714 |
Alexza Pharmaceuticals, Inc.
||Randall Stoltz, MD
||West Pharmaceutical Services, GFI Research Center, Evansville, IN 47714
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 5, 2007
||March 5, 2007
||United States: Food and Drug Administration
Keywords provided by Alexza Pharmaceuticals, Inc.:
Schizophrenia, Staccato Loxapine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action