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Healthy ParticipantsPhase 1NCT04729101

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants

A Phase 1 study testing Vonoprazan and Lansoprazole in people with Healthy Participants, 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

To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of vonoprazan (20 mg) and lansoprazole (30 mg) following single (Day 1) and multiple doses (Day 7). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Vonoprazan and Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
28 Jan 2021to 26 Jun 2021
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

  • Participants must fulfill all the following inclusion criteria to be eligible for participation in the study:
  • Healthy, adult, male or female 18 - 55 years of age, inclusive, at screening.
  • Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting.
  • Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2 at screening.
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
  • Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) < upper limits of the clinical laboratory reference range (one recheck is permissible).
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  • A female of childbearing potential is either sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or is using one of the following acceptable birth control methods:
  • hormonal oral contraceptives, vaginal ring, transdermal patch, or hormone releasing intrauterine device for at least 3 months prior to the first dosing and with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study.
  • Depot/implantable hormone (e.g., Depo-Provera®, Implanon®) for at least 3 months prior to the first dosing and throughout the study.
  • In addition, female participants of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 28 days after the last dose.
  • A female of non-childbearing potential has undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
  • hysteroscopic sterilization;
  • bilateral tubal ligation or bilateral salpingectomy;
  • hysterectomy;
  • bilateral oophorectomy;
  • or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
  • A non-vasectomized, male participant must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dosing. A male who has been vasectomized less than 4 months prior to study first dosing must follow the same restrictions as a non-vasectomized male).
  • If male, must agree not to donate sperm from the first dosing until 90 days after the last dosing.
  • Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Who cannot join

  • Participants must not be enrolled in the study if they meet any of the following criteria:
  • Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the principal investigator (PI) or designee.
  • History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
  • History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s), its excipients, related compounds, or lidocaine.
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  • Clinically significant gastrointestinal (GI) disorder (e.g., gastric ulcer (GU), Gastroesophageal reflux disease (GERD), impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, bowel obstruction, bariatric surgery, cholecystitis [including history of cholecystectomy], and/or appendectomy).
  • Positive result for H. pylori breath test at screening.
  • Had diarrhea or vomiting within 48 hours prior to check-in.
  • Has nasal abnormalities that could affect pH probe insertion.
  • Cannot tolerate placement of the pH probe.
  • Female participants with a positive pregnancy test at screening or check-in or who are lactating.
  • Positive urine drug or alcohol results at screening or check-in.
  • Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
  • Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
  • Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
  • Fridericia's correction to the QT interval (QTcF) interval is >460 msec (males) or >470 msec (females) or has electrocardiogram (ECG) findings deemed abnormal with clinical significance by the PI or designee at screening.
  • Estimated creatinine clearance <80 mL/min at screening.
  • The participant has serum creatinine >1.22 mg/dL at screening or check-in.
  • Unable to refrain from or anticipates the use of:
  • Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. After randomization, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee. Topical lidocaine may be administered for pH probe insertion. Hormone replacement therapy will also be allowed.
  • Any drugs known to be significant inducers of CYP3A4/5, CYP1A2, and/or CYP2C19 for 28 days prior to the first dosing and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK / PD interaction with study drug.
  • Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.
  • Donation of blood or significant blood loss within 56 days prior to the first dosing.
  • Plasma donation within 7 days prior to the first dosing.
  • Participation in another clinical study within 30 days prior to the first dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion, 2420 W Baseline Rd,

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan (20 mg) and Lansoprazole (30 mg) in Healthy Subjects

To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of vonoprazan (20 mg) and lansoprazole (30 mg) following single (Day 1) and multiple doses (Day 7).

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.).

Being tested
Vonoprazan, Lansoprazole
Keywords
Vonoprazan, Lansoprazole

What participants receive

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

  • VonoprazanDrug

    Oral tablet

  • LansoprazoleDrug

    Oral capsule

Study groups in NCT04729101
Study groupRoleWhat they receive
Treatment A (vonoprazan)ExperimentalParticipants will be randomized to receive vonoprazan (treatment A) and lansoprazole (treatment B) in a two period sequence, following either treatment sequence AB or BA. There will be a washout period of at least 7 days between Period 1 and Period 2. Vonoprazan will be administered via 20 mg oral tablet once daily on Day 1 through to Day 7 in a period, where each period is up to 8 days.
Receives: Drug: Vonoprazan
Treatment B (lansoprazole)Active comparatorParticipants will be randomized to receive vonoprazan (treatment A) and lansoprazole (treatment B) in a two period sequence, following either treatment sequence AB or BA. There will be a washout period of at least 7 days between Period 1 and Period 2. Lansoprazole will be administered via 30 mg oral capsule once daily on Day 1 through to Day 7 in a period, where each period is up to 8 days.
Receives: Drug: Lansoprazole

What is being measured

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

  1. Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration

    Calculated as: Time pH >4*100/total actual monitoring period time. Gastric pH was measured continuously over a 24-hour period on Days 1 and 7 of Periods 1 and 2, using a pH and pressure sensitive probe and ambulatory pH recording system. A pH recording was taken every second.

    Measured: Day 1 and Day 7 of each treatment period

  2. Mean Gastric pH Over a 24-hour Monitoring Period Following Study Drug Administration (pH0-24)

    The average gastric pH was a measure of the immediate effect on gastric pH and the duration of effect on gastric pH. Gastric pH was measured continuously over a 24-hour period on Days 1 and 7 of Periods 1 and 2, using a pH and pressure sensitive probe and ambulatory pH recording system. A pH recording was taken every second. The pH scale ranges from 0 to 14 with values below 7 being more acidic and values above 7 being more basic. Normal gastric pH is between 1.5 and 3.5.

    Measured: Day 1 and Day 7 of each treatment period

  3. Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24)

    Calculated using the Linear Trapezoidal with Linear Interpolation Method. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.

    Measured: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

  4. Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf)

    Calculated as the area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) + (Clast/Kel) where Clast is the last observed/measured concentration and Kel is the apparent first-order terminal elimination rate constant. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.

    Measured: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

  5. Maximum Observed Plasma Concentration (Cmax)

    Cmax was taken directly from bioanalytical data. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.

    Measured: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

  6. Time to Reach Cmax (Tmax)

    Taken from the clinical database as the difference in the time of administration and the time of the blood draw which was associated with the Cmax. If the maximum value occurred at more than one time point, Tmax was defined as the first time point with this value. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.

    Measured: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

  7. Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State (ss)

    Calculated using the Linear Trapezoidal with Linear Interpolation Method. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.

    Measured: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

  8. Cmax at Steady State (Cmax,ss)

    Cmax,ss was taken directly from bioanalytical data. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.

    Measured: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

  9. Tmax at Steady State (Tmax,ss)

    Taken from the clinical database as the difference in the time of administration and the time of the blood draw which was associated with the Cmax,ss. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.

    Measured: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

Timeline

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

  1. First posted28 Jan 2021
  2. Study start28 Jan 2021
  3. Primary completion12 Jun 2021
  4. Study completion26 Jun 2021

Resources

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04729101
Sponsor's protocol ID
VONO-103
Status last verified
Jun 2022
First submitted
19 Jan 2021
Last updated
31 Mar 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laine L, Sharma P, Mulford DJ, Hunt B, Leifke E, Smith N, Howden CW. Pharmacodynamics and Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan and the Proton Pump Inhibitor Lansoprazole in US Subjects. Am J Gastroenterol. 2022 Jul 1;117(7):1158-1161. doi: 10.14309/ajg.0000000000001735. Epub 2022 Mar 16.

    PubMed 35294415

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vonoprazan and Lansoprazole 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 19 inclusion and 26 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 31 Mar 2023. 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 31 Mar 2023). 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?

Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration (time frame: Day 1 and Day 7 of each treatment period). The study lists 9 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 NCT04729101, which also lists 1 linked publication.

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 31 Mar 2023.

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