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

NCT03688022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-05-15

No results posted yet for this study

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

DRUG

MT-7117

MT-7117

DRUG

PPI

Proton pump inhibitor

DIETARY_SUPPLEMENT

Acidic beverage

Acidic beverage

Sponsors & Collaborators

  • Mitsubishi Tanabe Pharma America Inc.

    lead INDUSTRY

Principal Investigators

  • General Manager · Mitsubishi Tanabe Pharma Europe Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2018-12-22
Completion
2018-12-22

Countries

  • Germany

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688022 on ClinicalTrials.gov