NCT04558216

Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Phathom Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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	20 mg tablets administered orally
DRUG	Rifampin	600 mg (Two 300 mg capsules)

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-02-07
• Completion: 2021-02-19
• First posted: 2020-09-22
• Last updated: 2022-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study