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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516305
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Clinilabs, Inc.
Information provided by (Responsible Party):
EngageTherapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Staccato Alprazolam 1 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects receive a single dose of Staccato Alprazolam 1 mg
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Open-Label, Non-Randomized, Single-Dose, Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smoker Versus Non-Smoker Healthy Adult Volunteers
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
Experimental: Staccato Alprazolam 1 mg
a single inhaled dose
Drug: Staccato Alprazolam 1 mg
alprazolam I mg administered via the Staccato hand-held inhaler device system.




Primary Outcome Measures :
  1. Pharmacokinetics (PK) : Maximum observer drug concentration (Cmax) [ Time Frame: 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. ]
    Cmax of alprazolam in smokers compared to non-smokers

  2. PK: Area under the concentration versus time curve (AUC)from Zero to Infinity (AUC[0-∞] [ Time Frame: 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. ]
    AUC[0-∞] of alprazolam in smokers compared to non-smokers


Secondary Outcome Measures :
  1. PK;: time after administration of a drug when the maximum plasma concentration is reached (Tmax) [ Time Frame: 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. ]
    Tmax of alprazolam in smokers compared to non-smokers

  2. PK: half-life (t1/2) [ Time Frame: 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. ]
    t1/2 of alprazolam in smokers compared to non-smokers



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • These inclusion criteria (items 1-8) apply to all subjects, smokers and non-smokers:

I. Healthy male and female subjects between the ages of21 to 50 years, inclusive.

2. Body mass index (BMI) >/= 18 and </= 30 kg/m2, inclusive.

3. 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.

4. 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.

5. Normal spirometry at screening as demonstrated by FEVI +/- 80% of predicted and FVC +/- 80% of predicted.

6. 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.

7. 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.

8. 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):

9. A history of smoking> 15 cigarettes/day currently and for at least the last 2 years.

10. Serum cotinine +/-500 ng/mL at Screening Visit I.

Nonsmokers must meet the following inclusion criteria (items 11-12):

11. A history of never smoking> 5 cigarettes/day and not smoking at all for at least the last 2 years prior to Visit I.

12. Serum cotinine :o 40 ng/mL at Screening Visit I and a negative urine cotinine test at Visit 2 Day-I.

Exclusion Criteria:

  1. Treatment with an investigational drug within 30 days ( or within 5 half-lives of the investigational drug, if>30 days) prior to Visit I.
  2. Significant hepatic, renal, gastroenterologic, cardiovascular endocrine, neurologic (including history of seizures or stroke), or hematologic disease.
  3. Any acute illness in the 5 days prior to Visit 2.
  4. Upper respiratory tract infection within 6 weeks of Visit 2 or bronchitis or pneumonia within 6 months of Visit 2.
  5. Use of a bronchodilator for the treatment of wheezing within 12 months of Visit I.
  6. Diagnosis of an active or chronic pulmonary disease.
  7. Lung resection or other pulmonary surgery within 12 months of Visit I.
  8. A history of allergy or intolerance to alprazolam.
  9. 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.
  10. A history within the past 2 years of drug or alcohol dependence or abuse.
  11. Positive test for alcohol or a positive urine screen for drugs of abuse at screening
  12. A positive HIV test.
  13. Breastfeeding or a positive pregnancy test at screening (female subjects).
  14. Clinically significant ECG abnormality.
  15. Hypotension or hypertension, at screening or baseline.
  16. Poor veins in the opinion of the Investigator or the Investigator's designee such that the participant is judged to likely have difficult venipuncture during the study.
  17. 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.
  18. Participation in another clinical trial within 2 months of the beginning of the present study, or blood donation or comparable blood loss (>350mL) within 2 months before the present study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516305


Locations
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United States, New Jersey
Clinilabs Research Unit
Eatontown, New Jersey, United States, 07724
Sponsors and Collaborators
EngageTherapeutics, Inc.
Clinilabs, Inc.
Investigators
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Principal Investigator: M. Shenouda, MD Clinilabs, Inc.
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Responsible Party: EngageTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03516305    
Other Study ID Numbers: EPK-002
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action