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BiPolarPhase 1NCT02184767

Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication

A Phase 1 study testing ADASUVE® in people with BiPolar, run by Teva Branded Pharmaceutical Products R&D, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to assess the pharmacokinetics of loxapine and will be using plasma concentration data obtained over 48 hours after administration of the study drug Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
BiPolar
What is being tested?
ADASUVE®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
Jul 2014to May 2015
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 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written informed consent is obtained from each patient's parent or legal guardian and written assent is obtained from each patient.
  • The patient is a boy or girl 10 through 17 years of age.
  • The patient is within the 2.5 to 97.5 percentile for body mass index (BMI) on the basis of age and sex and is within the following weight range, as appropriate:
  • boys: more than 27 kg and 127 kg or less
  • girls: more than 27 kg and 111 kg or less
  • The patient has a documented history of schizophrenia, bipolar disorder, autism, or any condition for which the use of antipsychotic medication (eg, risperidone, olanzapine, aripirazole, haloperidol, etc.) is warranted and/or administered. Note: Patients currently receiving treatment for any condition must be on a stable regimen (dose and frequency) for a minimum of 28 days before administration of ADASUVE.
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  • The patient is in good general health as determined by a complete medical history (including psychiatric and respiratory), clinical laboratory tests (include hematology, serum chemistry, and urinalysis), physical examination, body weight, 12-lead ECG, spirometry, vital signs measurements (blood pressure [systolic and diastolic], heart rate, body temperature, and respiratory rate), pulse oximetry, chest auscultation, neurologic examination, suicidality assessment, and concomitant medication usage inquiry.
  • Female patients who are postmenarche or sexually active must have a negative pregnancy test result, must have exclusively same sex partners or be using an acceptable method of contraception, and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of ADASUVE. Acceptable methods of contraception include abstinence or an intrauterine device (known to have a failure rate of less than 1% per year).
  • The patient has negative alcohol test and urine drug screen (UDS) results. A positive UDS result with appropriate medical explanation (eg, prescribed amphetamines) may be permitted after consultation with the medical monitor. Note: The UDS will also detect the presence of tetrahydrocannabinol (THC). A positive result for THC may be permitted after discussion with the sponsor if the result is low and is consistent (eg, positive at all predose assessments). If a patient tests negative for THC at screening, the result must remain negative at check-in for the patient to be eligible for study participation.
  • The patient and parent/legal guardian must be willing and able to comply with study restrictions and to remain at the investigational center for the required duration at each visit.

Who cannot join

  • The patient has any clinically significant uncontrolled medical condition (treated or untreated) other than the conditions specified in inclusion criterion d.
  • The patient has a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis, chronic bronchitis, emphysema, or other lung disease associated with bronchospasm.
  • The patient has acute respiratory signs or symptoms (eg, wheezing)
  • The patient currently has or has a known history of the following:
  • cardiovascular disease (including, but not limited to, myocardial infarction or ischemic heart disease, heart failure, or conduction abnormalities)
  • cerebrovascular disease
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  • conditions that predispose him or her to hypotension (including, but not limited to, dehydration, hypovolemia, or treatment with antihypertensive medications or other drugs that affect blood pressure or reduce heart rate)
  • seizure disorder except a history of infantile febrile seizures
  • The patient is pregnant or lactating.
  • The patient is febrile.
  • The patient has any other disease or condition that, in the investigator's or medical monitor's opinion, would present undue risk to the patient, or may confound the interpretation of study results.
  • The patient has taken any of the following drugs, substances, or foods:
  • any investigational drug within 30 days or 5 half-lives (whichever is longer) before administration of ADASUVE or, in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before administration of ADASUVE
  • current use of medications to treat airway disease such as asthma or COPD
  • loxapine or amoxapine within the last 30 days
  • more than 21 units of alcohol per week within the past 2 years or a history of alcohol, narcotic, or any other substance abuse or dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR, American Psychiatric Association 2000). Note: A unit of alcohol is equal to 1 ounce of hard liquor, 5 ounces of wine, or 8 ounces of beer.
  • clinically significant excessive consumption of coffee, tea, and/or other caffeine-containing beverage or food (ie, 600 mg of caffeine or more per day, or 12-ounce caffeine-containing sodas, 30 ounces of chocolate, or 5 or more cups of coffee per day), or a combination of any of these beverages or foods within 2 weeks before the dose of ADASUVE
  • nicotine-containing products (including but not limited to cigarettes, cigars, and chewing or dipping tobacco) within 12 months before administration of ADASUVE or use of topical or oral nicotine preparations for smoking cessation within the past 3 months before administration of ADASUVE
  • The patient has a known sensitivity or idiosyncratic reaction to loxapine or amoxapine, any compound present in the study formulation, any metabolites, or any other related compounds.
  • The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions.
  • The patient has a known history of contraindications to anticholinergics (eg, bowel obstructions, urinary retention, or acute glaucoma).
  • The patient has any procedure or disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery; a history of appendectomy is allowed).
  • The patient has received or donated blood or blood products (eg, plasma or platelets) in the 3 months before administration of ADASUVE or has made more than 2 blood (≥ 450 mL) or blood product donations within the 12 months before administration of ADASUVE, or has plans to donate during the study or within 3 months after completion of the study.
  • The patient has 1 or more clinical laboratory test values outside the range specified below, or any other clinically significant laboratory abnormality, as determined by the investigator or medical monitor:
  • hemoglobin value of less than 11.0 g/dL
  • more than twice the upper limit of the normal range (ULN)
  • total bilirubin value of more than the ULN
  • With the exception of the conditions specified in inclusion criterion d, the patient has had, within 4 weeks before administration of ADASUVE, a clinically significant illness or, within 1 week before administration of ADASUVE, has had any acute illness, or at screening or on the day before administration of ADASUVE, has symptoms of any clinically significant or acute illness.
  • The patient has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus, or has a known positive human immunodeficiency virus (HIV) history.
  • The patient is unable to tolerate direct venipuncture.
  • The patient has blood pressure outside the range of 90 to 140 mm Hg (systolic) or 50 to 90 mm Hg (diastolic). Note: Only 2 rechecks are permissible for study eligibility purposes.
  • The patient has, after resting for 5 minutes, an oxygen saturation at less than 95%. Note: Only 2 rechecks are permissible for study eligibility purposes.
  • The patient has evidence of a clinically significant ECG abnormality.
  • The patient has a forced expiratory volume in 1 second (FEV1) of less than 80% of predicted value on spirometry.
  • The patient is unlikely to comply with the study protocol, or is unsuitable for any other reasons, as judged by the investigator.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Teva Investigational Site 12468

    Atlanta, Georgia

  • Teva Investigational Site 12469

    Cincinnati, Ohio

Other trials in United States

About this study

Official title: A Nonrandomized, Open-Label, Multicenter, Phase 1 Study to Assess the Safety and Pharmacokinetics of ADASUVE® (STACCATO® Loxapine for Inhalation) at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication

This study is to assess the pharmacokinetics of loxapine and will be using plasma concentration data obtained over 48 hours after administration of the study drug

Conditions
BiPolar
Being tested
ADASUVE®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADASUVE®Drug

    Also called STACCATO® Loxapine for Inhalation

    ADASUVE® 2.5, 5, or 10 mg

Study groups in NCT02184767
Study groupRoleWhat they receive
ADASUVE®Experimentaloral inhalation using a single-use, hand-held, inhaler; dosage determined by the investigator according the participants weight
Receives: Drug: ADASUVE®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t)

    Measured: 48 hours

Secondary outcomes (10)

  1. area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

    Measured: 48 hours

  2. ratio of AUC0-t to AUC0-inf (AUC0-t/AUC0-inf)

    Measured: 48 hours

  3. maximum observed plasma drug concentration (Cmax)

    Measured: 48 hours

  4. time to maximum observed concentration (tmax)

    Measured: 48 hours

  5. apparent terminal elimination rate constant (Kel)

    Measured: 48 hours

  6. elimination half-life (t½)

    Measured: 48 hours

  7. apparent clearance (CL/F)

    Measured: 48 hours

  8. volume of distribution (V/F)

    Measured: 48 hours

  9. The palatability of ADASUVE will be performed using a visual analog scale (VAS)

    Measured: 2 1/2 weeks

  10. Summary of participants with adverse events

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMar 2015
  4. Study completionMay 2015

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02184767
Sponsor's protocol ID
TV571-CNS-10018
Status last verified
Nov 2021
First submitted
3 Jul 2014
Last updated
12 Nov 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Dong M, Fukuda T, Selim S, Smith MA, Rabinovich-Guilatt L, Cassella JV, Vinks AA. Clinical Trial Simulations and Pharmacometric Analysis in Pediatrics: Application to Inhaled Loxapine in Children and Adolescents. Clin Pharmacokinet. 2017 Oct;56(10):1207-1217. doi: 10.1007/s40262-017-0512-x.

    PubMed 28205038

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADASUVE® in people with BiPolar, run by Teva Branded Pharmaceutical Products R&D, Inc. at 2 sites 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 10 inclusion and 35 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t) (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02184767, which also lists 1 linked publication.

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 12 Nov 2021.

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