A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects (PARKS)
13. juli 2026 opdateret af: Aquestive Therapeutics
A Phase 1, Multi-Site, Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of DESF in Pediatric Subjects ≥30 kg With a Personal History of Allergic Reactions at High Risk for Serious Reactions (PARKS: Pediatric Anaphylm Response, Kinetics, and Safety)
An open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of epinephrine administered as a single dose of DESF in pediatric subjects weighing ≥30 kg with a personal history of allergic reactions and are at high risk for serious allergic reactions.
All treated participants will receive a single dose of DESF on Study Day 1.
On Study Day 2, participants will return to the study site for an Oral Mucositis Assessment Scale (OMAS) assessment.
Studieoversigt
Detaljeret beskrivelse
This is a Phase 1, multi-site, open-label, single treatment study conducted in male and female pediatric subjects (age 7-17 years) who have a have a personal history of allergic reactions and are at high risk for serious allergic reactions. This study is designed to evaluate the pharmacokinetics (PK) of epinephrine administered as a single dose of DESF.
Up to 24 DESF treated pediatric participants are expected to be enrolled. The study population will consist of healthy, non-smoking, pediatric male and female participants aged 7 through 17 with a known history of allergic reactions that the investigators believe continue to remain at high risk of serious allergic reactions (e.g., anaphylaxis).
All treated participants will be administered a single, 12 mg, dose of DESF on Study Day 1. No other investigational product will be administered.
The expected maximum duration of an individual's participation in this study will be, approximately, 32 days including a 30-day Screening Period, a 1-day Treatment Period (Study Day 1) and a 1-day (±1 day) Post-treatment Follow-up (Study Day 2).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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Burlington, Ontario, Canada, L7L 6W6
- Halton Pediatric Allergy
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-
-
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Alabama
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Birmingham, Alabama, Forenede Stater, 35209
- Allervie Clinical Research
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California
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Los Angeles, California, Forenede Stater, 90095
- UCLA Pediatric Allergy & Immunology
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Colorado
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Maryland
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Wheaton, Maryland, Forenede Stater, 20902
- IAA Clinical Research
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New York
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Rochester, New York, Forenede Stater, 14607
- Rochester Regional Health AIR
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Texas
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Houston, Texas, Forenede Stater, 77030
- Texas Children's Hospital - Feigin Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84121
- J. Lewis Research Inc. / Foothill Family Clinic South
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Male and female children ages 7 through 17 years of age at the start of the Screening Period.
- Participants with a known history of allergic reactions with an active prescription for epinephrine, and who (in the judgement of the investigator) are at high risk for serious allergic reactions (e.g., anaphylaxis).
- Participant has a body weight ≥30 kg (66 lbs).
- Participant is within the 5th and 95th percentiles, inclusive, for weight by age (according to CDC growth charts).
Exclusion Criteria:
- Any current or past medical conditions such as significant systemic diseases that, in the investigator's opinion, might significantly affect pharmacodynamic responses to DESF.
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
- Known intolerance or hypersensitivity to any component of DESF.
- Participant has a disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of DESF.
- Positive urine drug screen, saliva alcohol test, or urine cotinine test at Screening or prior to administration of DESF on Study Day 1.
- Participant has participated in any clinical investigation within the 30 days prior to the planned administration of DESF on Study Day 1.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Single Dose of DESF
A single dose (12 mg) of DESF administered.
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DESF administered in the sublingual space
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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AUC0-10
Tidsramme: 0 til 10 minutter
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Baseline korrigeret plasma epinephrin koncentration-tid kurve fra tid nul til 10 minutter
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0 til 10 minutter
|
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AUC0-20
Tidsramme: 0 til 20 minutter
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Baseline korrigeret plasma epinephrin koncentration-tid kurve fra tid nul til 20 minutter
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0 til 20 minutter
|
|
AUC0-30
Tidsramme: 0 til 30 minutter
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Baseline korrigeret plasma epinephrin koncentration-tid kurve fra tid nul til 30 minutter
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0 til 30 minutter
|
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AUC0-45
Tidsramme: 0 til 45 minutter
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Baseline korrigeret plasma epinephrin koncentration-tid kurve fra tid nul til 45 minutter
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0 til 45 minutter
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Cmax
Tidsramme: 0 to 240 minutes post-dose
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Baseline Corrected Maximum Epinephrine Plasma Concentration
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0 to 240 minutes post-dose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. december 2024
Primær færdiggørelse (Faktiske)
14. marts 2025
Studieafslutning (Faktiske)
21. maj 2025
Datoer for studieregistrering
Først indsendt
17. december 2024
Først indsendt, der opfyldte QC-kriterier
13. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AQ109302
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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