Status:
COMPLETED
ADASUVE-Lorazepam Drug-Drug Interaction
Lead Sponsor:
Alexza Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone.
Detailed Description
The objective of this study is to compare the safety and pharmacodynamic profiles of concomitant administration of a single dose of ADASUVE and lorazepam (IM) compared to that of each agent administer...
Eligibility Criteria
Inclusion
- Male and female subjects between the ages of 18 to 50 years, inclusive.
- Body mass index (BMI) ≥18 and ≤32.
- Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for 9 days.
- 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 in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
- Female participants (if of child-bearing potential and sexually active) who agree to use a medically acceptable and effective birth control method throughout the study and for 30 days following the end of the study
- Male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method from the first dose and for 90 days following last dose of study drug. Male participants must refrain from donating sperm for the same period.
Exclusion
- Subject history, which includes: any cardiovascular disease or disorder; asthma, chronic obstructive lung disease, or any use of an inhaler prescribed for wheezing or bronchospasm must be excluded; sleep apnea; acute narrow-angle glaucoma; any neurological, gastrointestinal, hepatic, renal, hematologic, endocrine and/or metabolic disease or disorder; psychiatric illness or mental disorder except for short term situational anxiety or depression of \< 2 years duration; any substance abuse or addiction within the last 2 years; pregnancy within the past 6 months.
- Subjects who have taken prescription or nonprescription medication within 7 days of Visit 2.
- Subjects who have had an acute illness within the last 7 days of Visit 2.
- Subjects who have a history of HIV positivity.
- Subjects who test positive for alcohol or have a positive urine drug screen.
- Subjects who have a history of allergy or intolerance to loxapine or amoxapine.
- Subjects who have a history of allergy or intolerance to lorazepam or any other benzodiazepine.
- Subjects who have a history of allergy or intolerance to polyethylene glycol, propylene glycol, or benzyl alcohol
- Female subjects who have a positive pregnancy test at screening or at admission to Visit 2, or are breastfeeding.
- Subjects who have received an investigational drug within 30 days prior to the Screening Visit.
- Subjects who have any other disease(s), by history, physical examination, or laboratory abnormalities that, in the investigator's opinion, presents undue risk to the subject or may confound the interpretation of study results.
- Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving lorazepam or ADASUVE.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01877642
Start Date
June 1 2013
End Date
July 1 2013
Last Update
December 13 2017
Active Locations (1)
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1
Covance-Evansville
Evansville, Indiana, United States, 47710