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Trial record 1 of 1 for:    NCT04857307
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A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy

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: NCT04857307
Recruitment Status : Completed
First Posted : April 23, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief Summary:
The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Alprazolam Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of a Single Dose of Staccato Alprazolam in Adolescent Study Participants With Epilepsy
Actual Study Start Date : April 28, 2021
Actual Primary Completion Date : April 5, 2022
Actual Study Completion Date : April 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Alprazolam

Arm Intervention/treatment
Experimental: Staccato alprazolam
The study participants will receive a single dose of Staccato alprazolam.
Drug: Alprazolam
  • Pharmaceutical form: Inhalation powder.
  • Study participants will receive Staccato alprazolam at prespecified time-points.
Other Name: UCB7538




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam [ Time Frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. ]
    Cmax = Maximum plasma concentration.

  2. Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUC(0-t)) following single inhaled dose of Staccato alprazolam [ Time Frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. ]
    AUC(0-t) = Area under the plasma concentration-time curve from zero to the last quantifiable concentration.

  3. Area under the plasma concentration-time curve from time 0 to infinity (AUC) following single inhaled dose of Staccato alprazolam [ Time Frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. ]
    AUC = Area under the plasma concentration-time curve from time 0 to infinity.

  4. Apparent total body clearance (CL/F) following single inhaled dose of Staccato alprazolam [ Time Frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. ]
    CL/F = Apparent total body clearance.

  5. Percentage of participants with treatment-emergent adverse event (TEAEs) [ Time Frame: From baseline (Day 1) till end of Safety Follow-up (up to Day 9) ]
    An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant temporally associated with the use of IMP, whether or not considered related to the IMP.

  6. Percentage of participants with serious treatment-emergent adverse event (serious TEAEs) [ Time Frame: From baseline (Day 1) till end of Safety Follow-up (up to Day 9) ]

    A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

    a. Results in death c. Requires inpatient hospitalization or prolongation of existing hospitalization d. Results in persistent disability/incapacity e. Is a congenital anomaly/birth defect f. Important medical events.




Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be 12 to 17 years of age inclusive, at the time of signing the Informed Consent form (ICF) and the Assent form
  • Participant has an established diagnosis of focal, generalized, or focal and generalized epilepsy
  • Participant is in good general health as determined by medical evaluation including medical history and physical examination
  • Participants with a body weight ≥29 kg and body mass index (BMI) within the range 14 to 32 kg/m^2 (inclusive)
  • A male participant must agree to use contraception
  • A female participant is eligible to participate if she is not pregnant
  • Participant is capable of and provides assent, and the study participant's parent/legal representative provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the ICF, Assent form, and in this protocol
  • Participant has a lifetime history of never smoking >5 cigarettes/day, and a current history (for at least 6 months prior to Screening Visit) of not smoking at all (including e-cigarette and vaping products)
  • Participant has forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >80% predicted at Screening. In case of an out-of-range result, 1 repeat test will be allowed. If the readings are out-of-range again, the study participant will be excluded
  • Participant is willing and able to be confined to a clinical research facility for up to 36 hours (including 1 overnight stay) and comply with the study schedule and study requirements.

Note: If there are no clinical contraindications, as per Investigator's judgment, study participants may leave the clinical research facility after the 6-hour postdose assessments and return to the clinic on Day 2 for the 24-hour and 36-hour postdose assessments

  • Participant is currently taking at least 1 background antiepileptic drug (AED)
  • Participant is able to actuate the training device during Screening, according to Instructions for Use

Exclusion Criteria:

  • Participant has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, hematological, cerebrovascular, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of Investigational Medicinal Product (IMP); constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the Investigator
  • Participant has a known hypersensitivity to any components of the IMP or comparative drugs (and/or an investigational device) as stated in the protocol
  • Participant has severe chronic cardio-respiratory disease
  • Participant has history of acute narrow angle glaucoma, hydrocephalus, or Myasthenia Gravis
  • Participant has history or has current airway disease such asthma, cystic fibrosis, or chronic obstructive pulmonary disease
  • Participant has any acute respiratory signs/symptoms (ie, wheezing) and active acute respiratory infection (or within 1 week of dosing) with exception of symptoms of mild rhinitis
  • Participant has a known hypersensitivity to albuterol or similar short-acting beta2-agonist (SABA) that may be used as rescue medication administered in response to potential bronchospasm
  • Participant is taking strong liver inducing agents (eg, phenytoin, phenobarbital, carbamazepine, and primidone) or strong Cytochrome P450 3A4 (CYP3A4) inhibitors
  • Participant has a SpO2 measured by pulse oximetry <95% for >30 seconds during the Screening Visit

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): NCT04857307


Locations
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United States, Arkansas
Up0100 102
Little Rock, Arkansas, United States, 72205
United States, Florida
Up0100 110
Orlando, Florida, United States, 32806
United States, Hawaii
Up0100 103
Honolulu, Hawaii, United States, 96817
United States, Maryland
Up0100 101
Bethesda, Maryland, United States, 20817
United States, New York
Up0100 108
Rochester, New York, United States, 14642
United States, Ohio
Up0100 106
Cincinnati, Ohio, United States, 45229
United States, Tennessee
Up0100 105
Memphis, Tennessee, United States, 38103
United States, Washington
Up0100 107
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04857307    
Other Study ID Numbers: UP0100
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Epilepsy
Staccato alprazolam
Phase 1
Adolescents
STAP-001
Alprazolam
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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