Clinical trial NCT03688022: Relative Bioavailability and Drug-drug Interaction Study With MT-7117 and a Proton Pump Inhibitor
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Relative Bioavailability and DDI study with MT-7117 and a proton pump inhibitor
Lead sponsor: Mitsubishi Tanabe Pharma America Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open Label
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Pre-dose and up to 48 hours following each single dose
measure: Area under the plasma concentration time curve from time zero to last quantifiable concentration (AUC0-t)
timeFrame: Pre-dose and up to 48 hours following each single dose
measure: Area under the plasma concentration time curve from time zero to infinity (AUC0-inf)
timeFrame: Pre-dose and up to 48 hours following each single dose
Secondary outcomes:
measure: Incidence of adverse events (AEs) and serious AEs
timeFrame: up to 48 hours post dose
Other outcomes:
Locations:
city: Germany
country: Germany
facility: Investigational Centre(s)
Study officials:
affiliation: Mitsubishi Tanabe Pharma Europe Ltd
name: General Manager
role: STUDY_DIRECTOR
References: