NCT03688022

Relative Bioavailability and Drug-drug Interaction Study With MT-7117 and a Proton Pump Inhibitor

An Open Label, Multicentre, Randomised, 2-cohort, Sequential and Crossover Study to Assess the Relative Oral Bioavailability of MT-7117 Higher Content Tablets Versus MT-7117 Lower Content Tablets and the Pharmacokinetics of MT-7117 Under Various Gastric Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An open label, multicentre, randomised, 2-cohort, sequential and crossover study to assess the relative oral bioavailability of MT-7117 higher content tablets versus MT-7117 lower content tablets and the pharmacokinetics of MT-7117 under various gastric conditions (fed and fasted, and following administration of a proton pump inhibitor and an acidic beverage) in healthy subjects

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	MT-7117	MT-7117
DRUG	PPI	Proton pump inhibitor
DIETARY_SUPPLEMENT	Acidic beverage	Acidic beverage

Timeline

• Start date: 2018-10-25
• Primary completion: 2018-12-22
• Completion: 2018-12-22
• First posted: 2018-09-27
• Last updated: 2023-05-15

Locations

1 site across 1 country: Germany