HealthyPhase 1NCT03516305
Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers
A Phase 1 study testing Staccato Alprazolam 1 mg in people with Healthy, run by Engage Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Staccato Alprazolam 1 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2018to 1 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- These inclusion criteria (items 1-8) apply to all subjects, smokers and non-smokers:
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinilabs Research Unit
Eatontown, New Jersey, 07724
About this study
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
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
- Being tested
- Staccato Alprazolam 1 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staccato Alprazolam 1 mgDrug
alprazolam I mg administered via the Staccato hand-held inhaler device system.
| Study group | Role | What they receive |
|---|---|---|
| Staccato Alprazolam 1 mg | Experimental | a single inhaled dose Receives: Drug: Staccato Alprazolam 1 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) : Maximum observer drug concentration (Cmax)
Cmax of alprazolam in smokers compared to non-smokers
Measured: 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
Measured: 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)
Tmax of alprazolam in smokers compared to non-smokers
Measured: 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)
t1/2 of alprazolam in smokers compared to non-smokers
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start6 Apr 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects receive a single dose of Staccato Alprazolam 1 mg
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engage Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinilabs, Inc.
- Responsible party
- Sponsor
- Investigators
- M. Shenouda, MD, Principal investigator, Clinilabs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516305
- Sponsor's protocol ID
- EPK-002
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2018
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03516305
- Acronym / sponsor ID
- EPK-002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Engage Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinilabs, Inc.
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects receive a single dose of Staccato Alprazolam 1 mg
| Arm | Type | Receives |
|---|---|---|
| Staccato Alprazolam 1 mg | Experimental | Drug: Staccato Alprazolam 1 mga single inhaled dose |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- These inclusion criteria (items 1-8) apply to all subjects, smokers and non-smokers:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staccato Alprazolam 1 mgalprazolam I mg administered via the Staccato hand-held inhaler device system. | Drug | Staccato Alprazolam 1 mg |
Primary outcome
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
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
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Shenouda, MD principal investigator
Clinilabs, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Staccato Alprazolam 1 mg in people with Healthy, run by Engage Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.