Status and phase
Conditions
Treatments
About
This is an open-label, non-randomized, single dose, pharmacokinetic study in 36 healthy adult male and female volunteers, including 18 smokers and 18 non-smokers. All subjects will be administered a single inhaled dose of Staccato alprazolam 1 mg via hand-held inhaler. Blood samples will be drawn for pharmacokinetic analysis. Eligible subjects are admitted to Phase 1 unit for up to 48 hours. Subjects will receive a post-study safety phone call 14 days(± 2 days) after dosing.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
I. Healthy male and female subjects between the ages of21 to 50 years, inclusive.
Body mass index (BMI) >/= 18 and </= 30 kg/m2, inclusive.
Able to 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.
Willing and able to be confined to a clinical research facility for up to 48 hours (including 2 nights) and comply with the study schedule and study requirements.
Normal spirometry at screening as demonstrated by FEVI +/- 80% of predicted and FVC +/- 80% of predicted.
Adequate veins, as assessed by the Investigator or Investigator's designee, that are suitable for the required number and frequency of PK blood draws in this study.
In otherwise good general health as determined by a complete medical history, physical examination, 12-lead electrocardiogram (ECG), blood chemistry profile, hematology, serology (HIV-l/2Ab, HBsAg, HCV Ab), and urinalysis at screening.
Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.
Smokers must meet the following inclusion criteria (items 9-10):
A history of smoking> 15 cigarettes/day currently and for at least the last 2 years.
Serum cotinine +/-500 ng/mL at Screening Visit I.
Nonsmokers must meet the following inclusion criteria (items 11-12):
A history of never smoking> 5 cigarettes/day and not smoking at all for at least the last 2 years prior to Visit I.
Serum cotinine :o 40 ng/mL at Screening Visit I and a negative urine cotinine test at Visit 2 Day-I.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
36 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal