NCT04545944

Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants

An Open-Label, Fixed Sequence, Clinical Drug Interaction Study to Evaluate the Time-Dependent Inhibition Potential of Vonoprazan on a Sensitive CYP3A4 Substrate, Midazolam, in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Phathom Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To determine the time-dependent inhibition potential of repeated doses of oral vonoprazan on the pharmacokinetics (PK) of a single oral dose of midazolam, a sensitive cytochrome P450 3A4 (CYP3A4) substrate, 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 Volunteers

Interventions

Type	Name	Description
DRUG	Vonoprazan	20 mg tablets administered orally
DRUG	Midazolam	2 mg syrup administered orally

Timeline

• Start date: 2020-09-15
• Primary completion: 2020-11-13
• Completion: 2020-11-25
• First posted: 2020-09-11
• Last updated: 2023-03-17
• Results posted: 2023-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study