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

NCT ID: NCT03688022

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2018-12-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

MT-7117

Intervention Type: DRUG

MT-7117

PPI

Intervention Type: DRUG

Proton pump inhibitor

Acidic beverage

Intervention Type: DIETARY_SUPPLEMENT

Acidic beverage

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)

Group Type: EXPERIMENTAL

MT-7117

Intervention Type: DRUG

MT-7117

PPI

Intervention Type: DRUG

Proton pump inhibitor

Acidic beverage

Intervention Type: DIETARY_SUPPLEMENT

Acidic beverage

Interventions

MT-7117

MT-7117

Intervention Type: DRUG

PPI

Proton pump inhibitor

Intervention Type: DRUG

Acidic beverage

Acidic beverage

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mitsubishi Tanabe Pharma America Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Mitsubishi Tanabe Pharma Europe Ltd

Locations

Investigational Centre(s)

Germany, , Germany

Countries

Germany

Other Identifiers

2018-002718-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MT-7117-E03

Identifier Type: -

Identifier Source: org_study_id