Relative Bioavailability and Drug-drug Interaction Study With MT-7117 and a Proton Pump Inhibitor (MT-7117 BA DDI)

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: MT-7117; Drug: PPI; Dietary supplement: Acidic beverage

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Germany, Germany
    • Investigational Centre(s)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Additional screening criteria check may apply for qualification:

• Able to provide written informed consent to participate in this study.
• Healthy and free from clinically significant illness or disease.
• Caucasian male and female subjects aged 18 to 55 years (inclusive) that are willing and able to practice acceptable birth control for the duration of the study, as defined in the Protocol.
• A body weight of ≥50.0 kg and a body mass index (BMI) (Quetelet index) ranging from 18.0 to 30.0 kg/m2 (inclusive) at Screening.
• Subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements.

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

• Previously having received MT-7117.
• Participation in more than 3 clinical studies* involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study* involving administration of an IMP within 12 weeks (or, if relevant, 5 half-lives, whichever is the longer) prior to the first dose. (*Disregarding any study Follow-up Periods).
• Subjects who have received any prescribed systemic or topical medication within 14 days (or, if relevant, 5 half-lives; whichever is longer) prior to the first dose of IMP.
• Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days (or, if relevant, 5 half-lives; whichever is longer) prior to the first dose of IMP.
• Clinically relevant abnormal medical history.
• Family history of long or short QT syndrome, hypokalaemia, syncope or Torsades de Pointes.
• Clinically significant 12-lead electrocardiogram (ECG) abnormalities.
• Blood pressure (supine) at Screening outside the range 90 to 140 mmHg (systolic) or 50 to 90 mmHg (diastolic).
• Presence or history of severe adverse reaction or allergy to any drug.
• Presence or history of drug abuse.
• Presence or history of alcohol abuse.
• Subjects who use tobacco or nicotine-containing products within 3 months.
• Test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 & HIV 2 antibodies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT-7117 BA and DDI (fasted); MT-7117 lower content tablets, higher content tablets, higher content tablets with PPI (fasted), higher content tablets with PPI and acidic beverage (fasted)	Drug: MT-7117; MT-7117; Drug: PPI; Proton pump inhibitor; Dietary supplement: Acidic beverage; Acidic beverage
Experimental: MT-7117 food effect and DDI (fed); MT-7117 higher content tablets (fasted and fed), higher content tablets with PPI (fed), higher content tablets with PPI and acidic beverage (fed)	Drug: MT-7117; MT-7117; Drug: PPI; Proton pump inhibitor; Dietary supplement: Acidic beverage; Acidic beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Pre-dose and up to 48 hours following each single dose
Area under the plasma concentration time curve from time zero to last quantifiable concentration (AUC0-t)	Pre-dose and up to 48 hours following each single dose
Area under the plasma concentration time curve from time zero to infinity (AUC0-inf)	Pre-dose and up to 48 hours following each single dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs) and serious AEs	up to 48 hours post dose

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma America Inc.
• Investigators: Study Director: General Manager, Mitsubishi Tanabe Pharma Europe Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): December 22, 2018
• Study Completion (Actual): December 22, 2018

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Relative Bioavailability and DDI study with MT-7117 and a proton pump inhibitor
• Other Study ID Numbers: MT-7117-E03; 2018-002718-11 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No