Healthy ParticipantsPhase 1NCT04558216
Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants
A Phase 1 study testing Vonoprazan and Rifampin in people with Healthy Participants, run by Phathom Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to assess the effect of multiple doses of rifampin on the pharmacokinetics of vonoprazan in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Vonoprazan and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 19 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant is male or female 18 to 45 years of age, inclusive, at Screening.
- The participant has a BMI 18 to 30 kg/m^2, inclusive, and has a body weight greater than 50 kg 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.
- Female participants of childbearing potential who may be sexually active with a non sterilized male partner must use an acceptable method of birth control (ie, 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 (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for 12 consecutive months and documented plasma folical stimulating hormone [FSH] level >40 IU/mL).
- Female participants must have a negative pregnancy test at Screening and 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 history of any clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, hematological, or endocrine disease or other abnormality that may affect the ability of the participant to participate in the study.
- The participant has a positive test result for coronavirus disease 2019 (COVID-19), hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies at Screening.
- The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >1.5 × ULN (with the exception of Gilbert's syndrome) at Screening or Check-in.
- The participant has serum creatinine >1.2 mg/dL or blood urea nitrogen >20 mg/dL at Screening or Check-in.
- The participant has any acute laboratory abnormality at Screening that precludes participation in the study, in the opinion of the investigator.
- The participant has a current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome and asymptomatic gallstones).
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- The participant has used any prescription (excluding hormonal birth control) or over the counter medications (including CYP3A4 inducers) except paracetamol (up to 2 g per day), including herbal or nutritional supplements, within 14 days (or 5 half-lives) before the first dose of study drug or throughout the study.
- 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.
- The participant has consumed caffeine- or xanthine containing products within 48 hours (or 5 half lives) before the first dose of study drug or throughout 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 addiction within the last year, 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 or throughout the study.
- 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 or throughout 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 (ie, allergy to rifampin, vonoprazan, or excipients, or any significant food allergy that could preclude a standard diet in the clinical unit).
- The participant has received study drug in another investigational study within 30 days of dosing.
- Female participant is pregnant or lactating, intends to become pregnant before, during, or within 4 weeks after participating in this study, or intends to donate ova during this time period.
- 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.
United States1 site
PPD Development, LP, 7551 Metro Center Drive, Suite 200
Austin, Texas, 78744
About this study
Official title: An Open-Label, Fixed-Sequence, Clinical Drug Interaction Study to Evaluate The Effect of a CYP3A-Inducer, Rifampin, on the Pharmacokinetics of Vonoprazan in Healthy Volunteers
The primary objective of this study is to assess the effect of multiple doses of rifampin on the pharmacokinetics of vonoprazan 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 Participants
- Being tested
- Vonoprazan, Rifampin
- Keywords
- Vonoprazan, CYP3A, Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
20 mg tablets administered orally
RifampinDrug
600 mg (Two 300 mg capsules)
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan single doses / rifampin single doses | Experimental | Participants will be administered a single oral dose of 20 mg of vonoprazan oral tablets on Day 1 and Day 17. Participants will also be administered single daily doses of 600 mg rifampin oral capsules on Days 3 through 18. Receives: Drug: Vonoprazan; Drug: Rifampin |
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 and Day 17: 0.25 hours pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 30, 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 and Day 17: 0.25 hours pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Vonoprazan
Measured: Day 1 and Day 17: 0.25 hours pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 30, 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.
- First posted22 Sep 2020
- Study start30 Sep 2020
- Primary completion7 Feb 2021 (estimated)
- Study completion19 Feb 2021 (estimated)
Why it stopped: Withdrawn due to unavailability of rifampin for clinical trial use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phathom Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Phathom Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558216
- Sponsor's protocol ID
- VONO-102
- Status last verified
- Feb 2022
- First submitted
- 15 Sep 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Fixed-Sequence, Clinical Drug Interaction Study to Evaluate The Effect of a CYP3A-Inducer, Rifampin, on the Pharmacokinetics of Vonoprazan in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04558216
- Acronym / sponsor ID
- VONO-102
- Conditions
- Healthy Participants
- Keywords
- Vonoprazan, CYP3A, Rifampin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to unavailability of rifampin for clinical trial use
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Phathom Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 7 Feb 2021 (estimated)
- Study completion
- 19 Feb 2021 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
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 of this study is to assess the effect of multiple doses of rifampin on the pharmacokinetics of vonoprazan in healthy participants.
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.).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan single doses / rifampin single doses | Experimental | Drug: Vonoprazan, Drug: RifampinParticipants will be administered a single oral dose of 20 mg of vonoprazan oral tablets on Day 1 and Day 17. Participants will also be administered single daily doses of 600 mg rifampin oral capsules on Days 3 through 18. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The participant is male or female 18 to 45 years of age, inclusive, at Screening.
- The participant has a BMI 18 to 30 kg/m^2, inclusive, and has a body weight greater than 50 kg 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.
- Female participants of childbearing potential who may be sexually active with a non sterilized male partner must use an acceptable method of birth control (ie, 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 (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for 12 consecutive months and documented plasma folical stimulating hormone [FSH] level >40 IU/mL).
- Female participants must have a negative pregnancy test at Screening and Check-in.
Key exclusion criteria (18 listed)
- The participant has a history of any clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, hematological, or endocrine disease or other abnormality that may affect the ability of the participant to participate in the study.
- The participant has a positive test result for coronavirus disease 2019 (COVID-19), hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies at Screening.
- The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >1.5 × ULN (with the exception of Gilbert's syndrome) at Screening or Check-in.
- The participant has serum creatinine >1.2 mg/dL or blood urea nitrogen >20 mg/dL at Screening or Check-in.
- The participant has any acute laboratory abnormality at Screening that precludes participation in the study, in the opinion of 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 |
|---|---|---|
| Vonoprazan20 mg tablets administered orally | Drug | Vonoprazan single doses / rifampin single doses |
| Rifampin600 mg (Two 300 mg capsules) | Drug | Vonoprazan single doses / rifampin single doses |
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 and Day 17: 0.25 hours pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 30, 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 and Day 17: 0.25 hours pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Vonoprazan
Time frame: Day 1 and Day 17: 0.25 hours pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 30, 36, and 48 hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- 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 and Rifampin in people with Healthy Participants, 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 18 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: withdrawn, as of the sponsor's last update on 2 Mar 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 and Day 17: 0.25 hours pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 30, 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?
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 2 Mar 2022.