A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants

Last updated: April 15, 2025
Sponsor: Phathom Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

Vonoprazan (Reference)

Vonoprazan ODT-1 or ODT-2 without Water

Vonoprazan ODT-1 or ODT-2 with Water

Clinical Study ID

NCT06831344
VPED-105
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of two vonoprazan orally disintegrating tablet formulations (ODT-1 or ODT-2) administered without water or mixed with water and administered via a syringe relative to the vonoprazan tablet in healthy participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant is 18 to 55 years of age, inclusive, at Screening.

  • The participant has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at Screening.

  • The participant is considered by the investigator to be in good general health asdetermined by medical history, clinical laboratory test results, vital signmeasurements, 12-lead electrocardiogram (ECG) results, and physical examinationfindings at Screening.

  • Female participants of reproductive potential must use an acceptable method of birthcontrol (ie, diaphragm with spermicide, intrauterine device, condom with foam orvaginal spermicide, oral contraceptives, or abstinence) from signing the informedconsent form (ICF) until 4 weeks after the last dose of study drug or be surgicallysterile (ie, hysterectomy or bilateral oophorectomy) or postmenopausal (defined asamenorrhea for 12 consecutive months and documented plasma follicle stimulatinghormone [FSH] level >40 IU/mL during Screening).

  • Female participants must have a negative pregnancy test at Screening and uponCheck-in.

  • The participant agrees to comply with all protocol requirements.

  • The participant is able to provide written informed consent.

Exclusion

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 antibodiesat Screening.

  • The participant has a positive test result for the presence of severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in.

  • The participant has a history of a clinically significant neurological,cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrinedisease or other abnormality that may impact the ability of the subject toparticipate.

  • The participant has current or recent (within 6 months) gastrointestinal conditionsthat would be expected to influence the absorption of drugs (eg, history ofmalabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis (EE)),frequent (more than once per week) occurrence of heartburn, or any surgicalintervention.

  • The participant has any other clinically significant findings on physicalexamination, clinical laboratory abnormalities, and/or ECG results that precludehis/her participation in the study, as deemed by the investigator.

  • The participant has used any prescription (excluding hormonal birth control) and/orover-the-counter medications (including Cytochrome P450 3A4 (CYP3A4) inducers)except acetaminophen (up to 2 g per day), including herbal or nutritionalsupplements, within 14 days before the first dose of study drug, and/or is expectedto require any such medication during the course of the study until the end ofconfinement on Study Day 23.

  • The participant has consumed grapefruit and/or grapefruit juice, Seville orange orSeville orange-containing products (eg, marmalade), or other food products that maybe CYP3A4 inhibitors (eg, vegetables from the mustard green family [kale, broccoli,watercress, collard greens, kohlrabi, Brussels sprouts, mustard] and charbroiledmeats) within 7 days before the first dose of study drug and/or is expected to beunable to abstain through the study.

  • The participant has consumed caffeine- or xanthine-containing products within 48hours (or 5 half-lives) before the first dose of study drug and/or is unable toabstain 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 lastyear or excessive alcohol consumption (regular alcohol intake >21 units per week formale subjects and >14 units of alcohol per week for female subjects; 1 unit is equalto approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1measure [25 mL] of spirits) or use of alcohol 48 hours before the first dose ofstudy drug.

  • The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at Screening or Check-in.

  • The participant is involved in strenuous activity or contact sports within 24 hoursbefore the first dose of study drug and during the study.

  • The participant has donated blood or blood products >450 mL within 30 days beforethe first dose of study drug.

  • The participant has a history of relevant drug and/or food allergies (ie, allergy tovonoprazan or excipients or any significant food allergy that could preclude astandard diet in the clinical unit).

  • The participant has received a study drug in another investigational study within 5-times the t1/2 of the study drug or 30 days of dosing, whichever is longer.

  • Female participants who are pregnant or lactating; intend to become pregnant before,during, or within 4 weeks after participating in this study; or intend to donate ovaduring this time period.

  • The participant is not suitable for entry into the study in the opinion of theinvestigator.

Study Design

Total Participants: 25
Treatment Group(s): 3
Primary Treatment: Vonoprazan (Reference)
Phase: 1
Study Start date:
February 14, 2025
Estimated Completion Date:
April 10, 2025

Connect with a study center

  • 7551 Metro Center Dr Ste 200

    Austin, Texas 78744
    United States

    Site Not Available

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