Erosive EsophagitisPhase 1NCT06391177
A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
A Phase 1 study testing Vonoprazan in people with Erosive Esophagitis and Heartburn, run by Phathom Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objective is to determine the pharmacokinetics (PK) of vonoprazan in breast milk of healthy lactating women who have received vonoprazan administered once daily or vonoprazan 20 mg administered twice daily for 4 consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Erosive Esophagitis, Heartburn, Symptomatic Nonerosive Gasroesophageal Reflux Disease
- 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 19 Sep 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant is a healthy lactating woman at least 18 years of age at the time of signing the informed consent form (ICF).
- The participant has delivered a normal term infant (at least 37 weeks gestation) and has been breastfeeding or actively pumping breast milk for at least 4 weeks postpartum prior to the first dose.
- The participant is willing to not breastfeed or otherwise use her breast milk during administration of vonoprazan and until at least 5 days after the last dose of the study drug.
- The participant has confirmed that her breastfed infant is able to feed from a bottle.
- The participant agrees to collect all breast milk from pre-dose to 24 hours after the morning dose administration on Day 4, using an electric pump.
- 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.
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- Participants of childbearing potential must use an acceptable method of birth control (ie, diaphragm with spermicide, intrauterine device, condom with foam or vaginal spermicide, oral contraceptives, or abstinence) or be surgically sterile (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). All participants must have a negative pregnancy test at Screening and before the first dose of study drug (Baseline).
- 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 pregnancy test at Screening or Baseline, is planning to become pregnant before, during, or within 4 weeks after participating in this study, or intends to donate ova during this time period, or is of childbearing potential and not using an effective contraceptive method.
- The participant has a history of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from one or both breasts.
- The participant has signs or symptoms of mastitis or other condition that would prevent the collection of milk from one or both breasts.
- The participant has undergone prior esophageal and/or gastrointestinal surgeries that may affect study drug absorption.
- The participant has undergone surgery (other than cesarean section) within 30 days before the first dose of study drug.
- 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.
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- The participant has any other clinically significant findings on physical examination, clinical laboratory abnormalities, or ECG results that preclude 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 cytochrome P450 3A4 inducers), 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 the Treatment Period. Use of multivitamins and acetaminophen (up to 2 g per day) is permissible.
- The participant has consumed grapefruit and/or grapefruit juice, Seville orange, or Seville orange-containing products (eg, marmalade) within 7 days before the first dose of study drug and/or is expected to be unable to abstain through the study.
- The participant is a smoker 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 or drug dependency within 12 months 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, Baseline, or Day 4 (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 a history of relevant drug and/or food allergies (ie, any significant food allergy that could preclude a standard diet in the clinical research unit).
- The participant has received study drug in another investigational study (including vonoprazan) within 30 days prior to start of the Screening Period.
- The participant has a history of hypersensitivity or allergies to vonoprazan or any of its formulation excipients (D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, ascorbic acid, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol 8000, titanium dioxide, or ferric oxide red).
- In the opinion of the investigator, the participant is not suitable for entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
The primary objective is to determine the pharmacokinetics (PK) of vonoprazan in breast milk of healthy lactating women who have received vonoprazan administered once daily or vonoprazan 20 mg administered twice daily for 4 consecutive days.
- Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Nonerosive Gasroesophageal Reflux Disease, Helicobacter Pylori Infection
- Being tested
- Vonoprazan
- Keywords
- Healthy participants, Helicobacter pylori infection, Erosive Esophagitis, Symptomatic nonerosive gasroesophageal reflux disease, Heartburn, Breast milk, Lactating women
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan 20 mg Once Daily | Experimental | Participants will be administered once-daily doses of vonoprazan 20 mg for 4 consecutive days (Days 1 through 4). Receives: Drug: Vonoprazan |
| Vonoprazan 20 mg Twice Daily | Experimental | Participants will be administered twice-daily doses of vonoprazan 20 mg for 4 consecutive days (Days 1 through 4). Receives: Drug: Vonoprazan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Drug Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Following the Morning Dose of Vonoprazan in Breast Milk
AUC from time 0 to 24 hours post-dose, calculated as: the sum of the product of the concentration of the interval and the width of the interval.
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Maximum Drug Concentration (Cmax) of Vonoprazan in Breast Milk
Maximum observed concentration after dosing.
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Minimum Drug Concentration (Cmin) of Vonoprazan in Breast Milk
Minimum observed concentration after dosing.
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Average Drug Concentration (Cavg) of Vonoprazan in Breast Milk
Average concentration, calculated as: AUC0-24/tau (tau=the difference between the end time of the last interval and dosing time).
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Time to Cmax (Tmax) of Vonoprazan in Breast Milk
Time to maximum observed concentration (actual midpoint of the interval in which Cmax was observed).
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Secondary outcomes (4)
Total Amount of Vonoprazan Excreted in Breast Milk
Total amount of drug excreted in breast milk over 24 hours; calculated as the sum of drug concentration × expressed milk volume in each collection interval over 24-hour period.
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Percentage of Vonoprazan Excreted in Breast Milk Relative to the Total Dose Received
Total amount of drug excreted over 24 hours relative to total dose administered; calculated as the sum of (total amount of drug excreted in each collection interval / total dose received over 24-hour period) * 100.
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Estimated Infant Daily Dose of Vonoprazan
Estimated weight adjusted daily dose consumed by the infant through breast milk; calculated as total amount of drug excreted over 24-hour period / weight of infant.
Calculation used the nominal infant weight of 6.0 kg which is the approximate 50th percentile for a 3-month old infant.
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Estimated Relative Infant Dose to the Total Maternal Dose Received of Vonoprazan
Percentage of daily infant dose relative to the daily maternal dose; calculated as (daily infant dose / daily maternal dose) * 100.
Measured: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start7 May 2024
- Primary completion13 Sep 2024
- Study completion19 Sep 2024
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 Erosive EsophagitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phathom Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391177
- Sponsor's protocol ID
- VONO-401
- Status last verified
- Feb 2025
- First submitted
- 25 Apr 2024
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
- ClinicalTrials.gov ID
- NCT06391177
- Acronym / sponsor ID
- VONO-401
- Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Nonerosive Gasroesophageal Reflux Disease, Helicobacter Pylori Infection
- Keywords
- Healthy participants, Helicobacter pylori infection, Erosive Esophagitis, Symptomatic nonerosive gasroesophageal reflux disease, Heartburn, Breast milk, Lactating women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Phathom Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine the pharmacokinetics (PK) of vonoprazan in breast milk of healthy lactating women who have received vonoprazan administered once daily or vonoprazan 20 mg administered twice daily for 4 consecutive days.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan 20 mg Once Daily | Experimental | Drug: VonoprazanParticipants will be administered once-daily doses of vonoprazan 20 mg for 4 consecutive days (Days 1 through 4). |
| Vonoprazan 20 mg Twice Daily | Experimental | Drug: VonoprazanParticipants will be administered twice-daily doses of vonoprazan 20 mg for 4 consecutive days (Days 1 through 4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The participant is a healthy lactating woman at least 18 years of age at the time of signing the informed consent form (ICF).
- The participant has delivered a normal term infant (at least 37 weeks gestation) and has been breastfeeding or actively pumping breast milk for at least 4 weeks postpartum prior to the first dose.
- The participant is willing to not breastfeed or otherwise use her breast milk during administration of vonoprazan and until at least 5 days after the last dose of the study drug.
- The participant has confirmed that her breastfed infant is able to feed from a bottle.
- The participant agrees to collect all breast milk from pre-dose to 24 hours after the morning dose administration on Day 4, using an electric pump.
Key exclusion criteria (17 listed)
- The participant has a positive pregnancy test at Screening or Baseline, is planning to become pregnant before, during, or within 4 weeks after participating in this study, or intends to donate ova during this time period, or is of childbearing potential and not using an effective contraceptive method.
- The participant has a history of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from one or both breasts.
- The participant has signs or symptoms of mastitis or other condition that would prevent the collection of milk from one or both breasts.
- The participant has undergone prior esophageal and/or gastrointestinal surgeries that may affect study drug absorption.
- The participant has undergone surgery (other than cesarean section) within 30 days before the first dose of study drug.
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 |
|---|---|---|
| VonoprazanOral tablet. | Drug | Vonoprazan 20 mg Once Daily, Vonoprazan 20 mg Twice Daily |
Primary outcome
Area Under Drug Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Following the Morning Dose of Vonoprazan in Breast Milk
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
AUC from time 0 to 24 hours post-dose, calculated as: the sum of the product of the concentration of the interval and the width of the interval.
Maximum Drug Concentration (Cmax) of Vonoprazan in Breast Milk
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Maximum observed concentration after dosing.
Minimum Drug Concentration (Cmin) of Vonoprazan in Breast Milk
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Minimum observed concentration after dosing.
Average Drug Concentration (Cavg) of Vonoprazan in Breast Milk
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Average concentration, calculated as: AUC0-24/tau (tau=the difference between the end time of the last interval and dosing time).
Time to Cmax (Tmax) of Vonoprazan in Breast Milk
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Time to maximum observed concentration (actual midpoint of the interval in which Cmax was observed).
4 secondary outcomes
Total Amount of Vonoprazan Excreted in Breast Milk
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Percentage of Vonoprazan Excreted in Breast Milk Relative to the Total Dose Received
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Estimated Infant Daily Dose of Vonoprazan
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Estimated Relative Infant Dose to the Total Maternal Dose Received of Vonoprazan
Time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Erosive Esophagitis and Heartburn, 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 9 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 25 Mar 2025. 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 25 Mar 2025). 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 Drug Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Following the Morning Dose of Vonoprazan in Breast Milk (time frame: Pre-dose on Day 4, and at regularly scheduled intervals through 24 hours after the morning dosing (0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, and 18-24 hours).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.