- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343364
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
June 16, 2023 updated by: Phathom Pharmaceuticals, Inc.
A Phase 1, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan (10 or 20 mg Once Daily) in Adolescents With Symptomatic Gastroesophageal Reflux Disease
The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).
Study Overview
Detailed Description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply.
(That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Phathom Medical Information
- Phone Number: 1-888-775-PHAT (7428)
- Email: medicalinformation@phathompharma.com
Study Locations
-
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Alabama
-
Mobile, Alabama, United States, 36604-1541
- University of South Alabama (USA) Physicians Group
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Preferred Research Partners, Inc.
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California
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Anaheim, California, United States, 92805
- Advanced Research Center - Elligo
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Georgia
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Morrow, Georgia, United States, 30260-2342
- Infinite Clinical Trials
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Louisiana
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Marrero, Louisiana, United States, 70072-3151
- Legacy Clinical Solutions: Tandem Clinical Research, LLC
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Boston Specialists
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Ohio
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Dayton, Ohio, United States, 45429
- PriMed Clinical Research
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Texas
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Austin, Texas, United States, 78726
- ARC Clinical Research at Four Points
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El Paso, Texas, United States, 79902
- Pediatric Gastro
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The participant is 12 to 17 years of age, inclusive, at the time of informed consent signing and throughout study participation.
- The participant has a body weight within the 5th through 95th percentile by age, inclusive, as determined by the National Center for Health Statistics.
- The participant has a medical history of symptoms of GERD for at least 3 months prior to screening, based on physical examination, current symptoms (eg, heartburn), or diagnostic tests (eg, pH or endoscopy). Notes in the medical records and/or other source documents such as prior endoscopies can be used to support the diagnosis.
- The participant has symptoms of at least moderate heartburn severity based on the GERD Symptom Assessment-Investigator scale performed at screening.
- The participant must be able to swallow study drug.
- Parent or legal guardian (ie, legally authorized representative [LAR]) is willing and able to complete the informed consent process and comply with study procedures and visit schedule. The participant will provide assent as applicable.
- A female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 2 weeks after the last dose of study drug.
Exclusion Criteria:
- The participant has used prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) within 7 days prior to randomization or requires their use during the Treatment Period.
- The participant has used sucralfate or antacids within 1 day prior to randomization or requires their use during the Treatment Period.
- The participant has received other agents affecting digestive organs, including muscarinic antagonists (eg, hyoscyamine), prokinetics, oral anticholinergic agents, prostaglandins, bismuth from 30 days prior to Day 1 or requires their use during the course of the study.
- The participant has received atazanavir sulfate or rilpivirine hydrochloride from 5 days prior to Day 1 or requires their use during the course of the study.
- The participant has received any investigational compound (including vonoprazan) within 30 days prior to the start of the Screening Period.
- The participant is an immediate family member or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, child, sibling) or who may have consented under duress.
- The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Period.
- The participant has undergone prior gastrointestinal surgeries such as fundoplication.
- The participant has any abnormal laboratory test values at the start of the Screening Period.
- The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, and titanium oxide, or red or yellow ferric oxide).
- The participant used any prescription (excluding hormonal birth control) or over-the-counter medications (including CYP3A4 inducers), including herbal or nutritional supplements, within 14 days (or 5 half-lives) before the first dose of study drug or throughout the study. NOTE: Acid suppressive therapies are considered separately under exclusion criteria 1 and 2.
- The participant has consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or other food products that may be CYP3A4 inhibitors (eg, vegetables from the mustard green family [kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard] and charbroiled meats) within 7 days (or 5 half-lives) before the first dose of study drug or throughout the study.
- Female participant has a positive pregnancy test at screening or check in or is lactating.
- The participant has a positive urine drug or alcohol result at screening.
- The participant has positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
- In the opinion of the investigator, the participant is not suitable for entry into the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vonoprazan 10 mg
Participants will receive vonoprazan 10 mg once daily for 14 days.
|
Oral Tablet
|
Experimental: Vonoprazan 20 mg
Participants will receive vonoprazan 20 mg once daily for 14 days.
|
Oral Tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Observed Drug Concentration at Steady State (Cmax-ss) of Vonoprazan
Time Frame: Day 7 and Day 14
|
Day 7 and Day 14
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Area Under the Plasma Concentration-time Curve During the Dosing Interval τ (AUCτ) of Vonoprazan
Time Frame: Day 7 and Day 14
|
Day 7 and Day 14
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Apparent Oral Clearance (CL/F) of Vonoprazan
Time Frame: Day 7 and Day 14
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Day 7 and Day 14
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Apparent Volume of Distribution (Vz/F) of Vonoprazan
Time Frame: Day 7 and Day 14
|
Day 7 and Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Phathom Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2022
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
June 13, 2023
Study Registration Dates
First Submitted
April 18, 2022
First Submitted That Met QC Criteria
April 18, 2022
First Posted (Actual)
April 25, 2022
Study Record Updates
Last Update Posted (Estimated)
June 19, 2023
Last Update Submitted That Met QC Criteria
June 16, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VPED-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroesophageal Reflux
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GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
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University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Klinikum Garmisch-PatenkirchenNot yet recruitingReflux, Gastroesophageal | Gastro-esophageal RefluxGermany
-
Mansoura UniversityWithdrawnGastroesophageal Reflux Disease
-
Cliniques universitaires Saint-Luc- Université...UnknownGastroesophageal Reflux DiseaseBelgium
-
King Chulalongkorn Memorial HospitalCompleted
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux Disease (GERD) | RefluxUnited States, Canada
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
Clinical Trials on Vonoprazan
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TakedaCompleted
-
Phathom Pharmaceuticals, Inc.Completed
-
Phathom Pharmaceuticals, Inc.RecruitingGastroesophageal Reflux DiseaseUnited States
-
Phathom Pharmaceuticals, Inc.CompletedHeartburn | Non-Erosive Gastro-Esophageal Reflux DiseaseUnited States
-
Phathom Pharmaceuticals, Inc.CompletedHeartburn | Non-Erosive Gastro-Esophageal Reflux DiseaseUnited States
-
TakedaCompleted
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TakedaCompletedGastric Ulcer, Duodenal Ulcer, and Reflux EsophagitisJapan
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityCompletedHelicobacter Pylori Eradication RateChina
-
Nanjing First Hospital, Nanjing Medical UniversityNot yet recruitingHelicobacter Pylori InfectionChina
-
Xijing Hospital of Digestive DiseasesRecruitingthe Eradication Rates of Helicobacter PyloriChina