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Phase 1 Completed N=27 Randomized Basic Science

A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants

Healthy Volunteers
Source: ClinicalTrials.gov NCT05366738 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan — 228; 216; 219 ng•h/mL

Summary

The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of vonoprazan 20 mg sprinkle capsule, either sprinkled on pudding or on applesauce, relative to a vonoprazan 20 mg tablet in healthy participants.

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
228; 216; 219
PRIMARY
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
238; 227; 231
PRIMARY
Maximum Observed Plasma Concentration (Cmax) of Vonoprazan
23.1; 22.4; 22.3
SECONDARY
Time to Maximum Observed Plasma Concentration (Tmax) of Vonoprazan
2.00; 2.01; 2.00
SECONDARY
Terminal Phase Half-life (t1/2) of Vonoprazan
7.50; 7.20; 7.29
SECONDARY
Apparent Total Body Clearance (CL/F) of Vonoprazan
83.9; 88.1; 86.6
SECONDARY
Apparent Volume of Distribution (Vz/F) of Vonoprazan
908; 915; 911
SECONDARY
Terminal Elimination Rate Constant (λz) of Vonoprazan
0.0924; 0.0963; 0.0951

Eligibility Criteria

Inclusion Criteria

  • The participant is male or female 18 to 55 years of age, inclusive, at Screening.
  • The participant has a body mass index 18 to 32 kg/m^2, inclusive, at Screening.
  • The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at Screening.
  • Male and female participants of reproductive potential must use an acceptable method of birth control (i.e., diaphragm with spermicide, intrauterine device, condom with foam or vaginal spermicide, oral contraceptives, or abstinence) from the signing of informed consent until 4 weeks after the last dose of study drug or be surgically sterile (i.e., vasectomy, hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for 12 consecutive months and documented plasma follicle stimulating hormone [FSH] level >40 international unit (IU)/mL during Screening).
  • Female participants must have a negative pregnancy test at Screening and upon Check-in.
  • The participant agrees to comply with all protocol requirements.
  • The participant is able to provide written informed consent.

Exclusion Criteria

  • The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at Screening.
  • The participant has a positive test result for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or Check-in.
  • The participant has a history of a clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality that may impact the ability of the participant to participate.
  • The participant has current or recent (within 6 months) gastrointestinal conditions that would be expected to influence the absorption of drugs (e.g., history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis [EE]), frequent (more than once per week) occurrence of heartburn, or any surgical intervention.
  • The participant has any other clinically significant findings on physical examination, clinical laboratory abnormalities, and/or ECG results that preclude his/her participation in the study, as deemed by the investigator.
  • The participant has used any prescription (excluding hormonal birth control) and/or over-the-counter medications (including CYP3A4 inducers) except acetaminophen (up to 2 g per day), including herbal or nutritional supplements, within 14 days before the first dose of study drug, and/or is expected to require any such medication during the course of the study until end of treatment period phase (ET) or end of study (EOS).
  • The participant has consumed grapefruit and/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 and/or is expected to be unable to abstain through the study.
  • The participant has consumed caffeine- or xanthine-containing products within 48 hours (or 5 half-lives) before the first dose of study drug and/or is unable to abstain through the study.
  • The participant is a smoker and/or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
  • The participant has a history of alcohol abuse and/or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week for male participants and >14 units of alcohol per week for female participants; 1 unit is equal to app
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05366738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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