NCT04729101

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Phathom Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
DRUG	Vonoprazan	Oral tablet
DRUG	Lansoprazole	Oral capsule

Timeline

• Start date: 2021-01-28
• Primary completion: 2021-06-12
• Completion: 2021-06-26
• First posted: 2021-01-28
• Last updated: 2023-03-31
• Results posted: 2023-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study