Healthy VolunteersPhase 1NCT05366738

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

A Phase 1 study testing Vonoprazan in people with Healthy Volunteers, run by Phathom Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Vonoprazan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 18 May 2022to 26 Jul 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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).

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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 approximately 1/2 pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits) or use of alcohol 48 hours before the first dose of study 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 hours before the first dose of study drug and during the study.
The participant has donated blood or blood products >450 mL within 30 days before the first dose of study drug.
The participant has a history of relevant drug and/or food allergies (i.e., allergy to vonoprazan or excipients or any significant food allergy that could preclude a standard diet in the clinical unit).
The participant has received a study drug in another investigational study within 30 days of dosing.
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 ova during this time period.
The participant is not suitable for entry into the study in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Development, LP
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Single-dose, Crossover Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants

Read the 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.).

Conditions: Healthy Volunteers
Being tested: Vonoprazan
Keywords: Vonoprazan, Gastroesophageal Reflux, Erosive Esophagitis
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VonoprazanDrug
Orally via tablet
VonoprazanDrug
Orally via sprinkle pellets

Study groups in NCT05366738
Study group	Role	What they receive
Treatment Sequence 1	Experimental	Participants assigned to Treatment Sequence 1 will receive vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 1, vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 3. Receives: Drug: Vonoprazan
Treatment Sequence 2	Experimental	Participants assigned to Treatment Sequence 2 will receive vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 1, vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 3. Receives: Drug: Vonoprazan
Treatment Sequence 3	Experimental	Participants assigned to Treatment Sequence 3 will receive vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 1, vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 3. Receives: Drug: Vonoprazan

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
Measured: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
Measured: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Maximum Observed Plasma Concentration (Cmax) of Vonoprazan
Measured: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.

Secondary outcomes (5)

Time to Maximum Observed Plasma Concentration (Tmax) of Vonoprazan
Measured: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Terminal Phase Half-life (t1/2) of Vonoprazan
Measured: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Apparent Total Body Clearance (CL/F) of Vonoprazan
Measured: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Apparent Volume of Distribution (Vz/F) of Vonoprazan
Measured: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Terminal Elimination Rate Constant (λz) of Vonoprazan
Measured: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202226 Jul 2022

First posted9 May 2022
Study start18 May 2022
Primary completion1 Jul 2022
Study completion26 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05366738
Sponsor's protocol ID: VPED-101
Status last verified: Sep 2023
First submitted: 4 May 2022
Last updated: 29 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, Single-dose, Crossover Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants
ClinicalTrials.gov ID: NCT05366738
Acronym / sponsor ID: VPED-101
Conditions: Healthy Volunteers
Keywords: Vonoprazan, Gastroesophageal Reflux, Erosive Esophagitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Phathom Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 18 May 2022 (actual)
Primary completion: 1 Jul 2022 (actual)
Study completion: 26 Jul 2022 (actual)
First posted: 9 May 2022 (actual)
Results: Posted 29 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment Sequence 1	Experimental	Drug: VonoprazanParticipants assigned to Treatment Sequence 1 will receive vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 1, vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 3.
Treatment Sequence 2	Experimental	Drug: VonoprazanParticipants assigned to Treatment Sequence 2 will receive vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 1, vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 3.
Treatment Sequence 3	Experimental	Drug: VonoprazanParticipants assigned to Treatment Sequence 3 will receive vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 1, vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 3.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VonoprazanOrally via tablet	Drug	Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3
VonoprazanOrally via sprinkle pellets	Drug	Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3

Primary outcome

Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Maximum Observed Plasma Concentration (Cmax) of Vonoprazan
Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.

5 secondary outcomes

Time to Maximum Observed Plasma Concentration (Tmax) of Vonoprazan
Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Terminal Phase Half-life (t1/2) of Vonoprazan
Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Apparent Total Body Clearance (CL/F) of Vonoprazan
Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Apparent Volume of Distribution (Vz/F) of Vonoprazan
Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Terminal Elimination Rate Constant (λz) of Vonoprazan
Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.

Results and safety

Results posted to the registry on 29 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vonoprazan 20 mg: Treatment Sequence 1	9	9
Vonoprazan 20 mg: Treatment Sequence 2	9	8
Vonoprazan 20 mg: Treatment Sequence 3	9	9

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan

Time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: ng•h/mL

Measure	Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding n = 26	Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce n = 26	Treatment C: Vonoprazan 20 mg Tablet n = 27
Value	228 (44.9)	216 (46.0)	219 (47.3)

Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding vs Treatment C: Vonoprazan 20 mg Tablet: Ratio of Geometric Least Square Means: 103.36 (90% CI 97.64 to 109.41)
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce vs Treatment C: Vonoprazan 20 mg Tablet: Ratio of Geometric Least Square Means: 97.83 (90% CI 92.42 to 103.56)

Population analysed: Measured in the pharmacokinetic (PK) population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan

Measure	Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding n = 26	Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce n = 26	Treatment C: Vonoprazan 20 mg Tablet n = 27
Value	238 (43.2)	227 (43.1)	231 (44.4)

Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding vs Treatment C: Vonoprazan 20 mg Tablet: Ratio of Geometric Least Square Means: 102.56 (90% CI 97.25 to 108.15)
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce vs Treatment C: Vonoprazan 20 mg Tablet: Ratio of Geometric Least Square Means: 97.61 (90% CI 92.55 to 102.93)

Population analysed: Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Vonoprazan

Measure	Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding n = 26	Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce n = 26	Treatment C: Vonoprazan 20 mg Tablet n = 27
Value	23.1 (44.2)	22.4 (41.9)	22.3 (45.3)

Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding vs Treatment C: Vonoprazan 20 mg Tablet: Ratio of Geometric Least Square Means: 103.96 (90% CI 96.49 to 112.00)
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce vs Treatment C: Vonoprazan 20 mg Tablet: Ratio of Geometric Least Square Means: 100.60 (90% CI 93.38 to 108.39)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 31. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding	0 of 26 (0%)	2 of 26 (7.7%)	0 of 26
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce	0 of 26 (0%)	2 of 26 (7.7%)	0 of 26
Treatment C: Vonoprazan 20 mg Tablet	0 of 27 (0%)	4 of 27 (14.8%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Phathom Pharmaceuticals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vonoprazan in people with Healthy Volunteers, run by Phathom Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan (time frame: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05366738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.