symptomatic gastroesophageal reflux disease MedDRA version: 20.1 Level: PT Classification code 10017885 Term: Gastrooesophageal reflux disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: vonoprazan 20 mg
Product Code: TAK-438
Pharmaceutical Form: Tablet
INN or Proposed INN: Vonoprazan
CAS Number: 881681-00-1
Current Sponsor code: TAK-438
Concentration unit: mg milligram(
Sponsors
Phathom Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 18 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).;Secondary Objective: Not applicable. ;Primary end point(s): 1. Maximum Observed Drug Concentration at Steady State (Cmax-ss) of Vonoprazan 2. Area Under the Plasma Concentration-time Curve During the Dosing Interval t (AUCt) of Vonoprazan 3. Apparent Oral Clearance (CL/F) of Vonoprazan 4. Apparent Volume of Distribution (Vz/F) of Vonoprazan;Timepoint(s) of evaluation of this end point: Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
United States
Contacts
Public ContactRegulatory Affairs
Phathom Pharmaceuticals, Inc.
Outcome results
None listed