Adults 6 to 11, any sex, with Gastroesophageal Reflux Disease. 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.
Maximum Drug Concentration at Steady-state (Cmax,ss) of VonoprazanPrimary· Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
Plasma pharmacokinetic (PK) parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Group
Value
95% CI
Vonoprazan 10 mg
16.2
9.31 – 27.1
Vonoprazan 20 mg
42.1
10.1 – 72.7
Area Under the Plasma Concentration-time Curve During the Dosing Interval τ at Steady State (AUCτ,ss) of VonoprazanPrimary· Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
Plasma PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Group
Value
95% CI
Vonoprazan 10 mg
88.3
51.7 – 121
Vonoprazan 20 mg
251
72.1 – 549
Apparent Oral Clearance (CL/F) at Steady State of VonoprazanPrimary· Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
Oral PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Group
Value
95% CI
Vonoprazan 10 mg
125
82.9 – 193
Vonoprazan 20 mg
118
36.4 – 278
Apparent Central Volume of Distribution (Vz/F) at Steady State of VonoprazanPrimary· Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
Plasma PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Group
Value
95% CI
Vonoprazan 10 mg
491
227 – 828
Vonoprazan 20 mg
444
164 – 1310
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 28.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The aim of this study is to evaluate the pharmacokinetic (PK) profile of vonoprazan (10 or 20 mg once daily \[QD\]) in children ≥ 6 to \< 12 years of age who have symptomatic Gastroesophageal Reflux Disease (GERD).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06953986 — A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA
· NA
· recruiting
NCT06955520 — Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
· NA
· recruiting
NCT07068607 — Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradicatio
· Phase 4
· recruiting
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
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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
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
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· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 19 December 2024
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/NCT06106022.