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

Sponsor

Mitsubishi Tanabe Pharma Development America, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03688022

Collaborator

(none)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

26.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: MT-7117 Drug: PPI Dietary Supplement: Acidic beverage	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Open LabelOpen Label

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 25, 2018

Actual Primary Completion Date :

Dec 22, 2018

Actual Study Completion Date :

Dec 22, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Incidence of adverse events (AEs) and serious AEs [up to 48 hours post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Centre(s)	Germany		Germany

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Development America, Inc.

Investigators

Study Director: General Manager, Mitsubishi Tanabe Pharma Europe Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mitsubishi Tanabe Pharma Development America, Inc.

ClinicalTrials.gov Identifier:

NCT03688022

Other Study ID Numbers:

MT-7117-E03
2018-002718-11

First Posted:

Sep 27, 2018

Last Update Posted:

Jan 22, 2019

Last Verified:

Jan 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mitsubishi Tanabe Pharma Development America, Inc.

Relative Bioavailability and DDI study with MT-7117 and a proton pump inhibitor

Study Results

No Results Posted as of Jan 22, 2019