NCT04729101 is a Phase 1 clinical trial of Vonoprazan in Healthy Participants, sponsored by Phathom Pharmaceuticals, Inc..

Who is sponsoring NCT04729101?

NCT04729101 is sponsored by Phathom Pharmaceuticals, Inc..

What drugs are being tested in NCT04729101?

Interventions in NCT04729101: Vonoprazan, Lansoprazole.

What condition does NCT04729101 study?

NCT04729101 studies Healthy Participants.

Is NCT04729101 still recruiting?

NCT04729101 is currently completed. Last updated 31 March 2023.

Are results published for NCT04729101?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-31 · How we verify

NCT04729101

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 31 March 2023

What this trial tests

Phase 1 trial testing Vonoprazan in Healthy Participants in 44 participants. Completed in 26 June 2021.

Timeline

28 January 2021

Primary endpoint
12 June 2021

26 June 2021

Quick facts

Lead sponsor	Phathom Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	44
Start date	28 January 2021
Primary completion	12 June 2021
Estimated completion	26 June 2021
Sites	1 location across United States

Drugs / interventions tested

Vonoprazan — full drug profile →
Lansoprazole (lansoprazole) — full drug profile →

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

Phathom Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · Day 1 and Day 7 of each treatment period

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.

Day 1

Group	Value	95% CI
Vonoprazan	62.40	± 23.351
Lansoprazole	22.61	± 17.309

Day 7

Group	Value	95% CI
Vonoprazan	87.81	± 15.708
Lansoprazole	42.32	± 25.597

Mean Gastric pH Over a 24-hour Monitoring Period Following Study Drug Administration (pH0-24) Primary · Day 1 and Day 7 of each treatment period

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.

Day 1

Group	Value	95% CI
Vonoprazan	4.606	± 1.0852
Lansoprazole	2.848	± 0.79923

Day 7

Group	Value	95% CI
Vonoprazan	5.903	± 0.84900
Lansoprazole	3.783	± 1.2000

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

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.

Group	Value	95% CI
Vonoprazan	200.6	± 80.954
Lansoprazole	2677	± 1357.1

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

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.

Group	Value	95% CI
Vonoprazan	229.5	± 98.841
Lansoprazole	2679	± 1361.0

Maximum Observed Plasma Concentration (Cmax) Primary · 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

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.

Group	Value	95% CI
Vonoprazan	21.79	± 8.3296
Lansoprazole	1110	± 411.88

Time to Reach Cmax (Tmax) Primary · 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

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.

Group	Value	95% CI
Vonoprazan	2.005	1.00 – 5.01
Lansoprazole	1.499	0.79 – 4.00

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

Group	Value	95% CI
Vonoprazan	261.4	± 104.18
Lansoprazole	3246	± 2396.4

Cmax at Steady State (Cmax,ss) Primary · 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

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.

Group	Value	95% CI
Vonoprazan	27.39	± 9.9928
Lansoprazole	1164	± 506.53

Tmax at Steady State (Tmax,ss) Primary · 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

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.

Group	Value	95% CI
Vonoprazan	2.005	1.53 – 5.00
Lansoprazole	1.510	0.75 – 4.02

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 to Day 35. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vonoprazan

Serious: 0/44 (0%)

Deaths: 0/44

Lansoprazole

Serious: 0/43 (0%)

Deaths: 0/43

Other adverse events (31 terms — click to expand)

Reaction	System	Vonoprazan	Lansoprazole
Diarrhoea	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Chapped lips	Gastrointestinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Gingival pain	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Nodule	General disorders	—	—
Vessel puncture site haematoma	General disorders	—	—
Oral herpes	Infections and infestations	—	—
Vaginitis gardnerella	Infections and infestations	—	—
Ear injury	Injury, poisoning and procedural complications	—	—
Post procedural discomfort	Injury, poisoning and procedural complications	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—
Weight decreased	Investigations	—	—
Muscle twitching	Musculoskeletal and connective tissue disorders	—	—
Pain in jaw	Musculoskeletal and connective tissue disorders	—	—
Burning sensation	Nervous system disorders	—	—
Dry throat	Respiratory, thoracic and mediastinal disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Nasal dryness	Respiratory, thoracic and mediastinal disorders	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—
Papule	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04729101 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Vonoprazan

Trials testing the same drug.

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NCT07242456 — Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID fo · Phase 2, PHASE3 · recruiting
NCT06811207 — Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication · Phase 3 · unknown

Other recruiting trials for Healthy Participants

Currently open trials in the same condition.

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Other Phathom Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT06831344 — A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Wa · Phase 1 · completed
NCT06391177 — A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once · Phase 1 · completed
NCT06106022 — A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease · Phase 1 · completed
NCT05366738 — A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonop · Phase 1 · completed
NCT05343364 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gast · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04729101 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Phathom Pharmaceuticals, Inc.
Last refreshed: 31 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04729101.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing