Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers

NCT03516305 | Completed Phase 1 FDA Drug

• 1 other identifier: EPK-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK) : Maximum observer drug concentration (Cmax)

  Cmax of alprazolam in smokers compared to non-smokers

  Sequential time points : pre-dose, and at 2, 5, 10 and 30 minutes, and at 1, 2, 4, 6, 12, 24 and 36 hours post-dose.

• PK: Area under the concentration versus time curve (AUC)from Zero to Infinity (AUC[0-∞]

  AUC\[0-∞\] of alprazolam in smokers compared to non-smokers

  Sequential time points : pre-dose, and at 2, 5, 10 and 30 minutes, and at 1, 2, 4, 6, 12, 24 and 36 hours post-dose.

Secondary Outcomes (2)

• PK;: time after administration of a drug when the maximum plasma concentration is reached (Tmax)

  Sequential time points : pre-dose, and at 2, 5, 10 and 30 minutes, and at 1, 2, 4, 6, 12, 24 and 36 hours post-dose.

• PK: half-life (t1/2)

  Sequential time points : pre-dose, and at 2, 5, 10 and 30 minutes, and at 1, 2, 4, 6, 12, 24 and 36 hours post-dose.

Study Arms (1)

Staccato Alprazolam 1 mg

EXPERIMENTAL

a single inhaled dose

Drug: Staccato Alprazolam 1 mg

Interventions

Staccato Alprazolam 1 mg DRUG

alprazolam I mg administered via the Staccato hand-held inhaler device system.

Staccato Alprazolam 1 mg

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• \. 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.
• \. 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.

You may not qualify if:

• Treatment with an investigational drug within 30 days ( or within 5 half-lives of the investigational drug, if\>30 days) prior to Visit I.
• Significant hepatic, renal, gastroenterologic, cardiovascular endocrine, neurologic (including history of seizures or stroke), or hematologic disease.
• Any acute illness in the 5 days prior to Visit 2.
• Upper respiratory tract infection within 6 weeks of Visit 2 or bronchitis or pneumonia within 6 months of Visit 2.
• Use of a bronchodilator for the treatment of wheezing within 12 months of Visit I.
• Diagnosis of an active or chronic pulmonary disease.
• Lung resection or other pulmonary surgery within 12 months of Visit I.
• A history of allergy or intolerance to alprazolam.
• Use of any other prescription or nonprescription medication--with the exception of acetaminophen, ibuprofen or ongoing doses of oral contraceptives or vitamins--within 5 days prior to study drug administration.
• A history within the past 2 years of drug or alcohol dependence or abuse.
• Positive test for alcohol or a positive urine screen for drugs of abuse at screening
• A positive HIV test.
• Breastfeeding or a positive pregnancy test at screening (female subjects).
• Clinically significant ECG abnormality.
• Hypotension or hypertension, at screening or baseline.

Sponsors & Collaborators

• Engage Therapeutics, Inc.: lead
• Clinilabs, Inc.: collaborator

Study Sites (1)

Clinilabs Research Unit

Eatontown, New Jersey, 07724, United States

Location

Study Officials

• M. Shenouda, MD

  Clinilabs, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects receive a single dose of Staccato Alprazolam 1 mg

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 4, 2018
• Study Start: April 6, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)