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

NCT03688022 | Completed Phase 1

• 2 other identifiers: MT-7117-E032018-002718-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Incidence of adverse events (AEs) and serious AEs

  up to 48 hours post dose

Study Arms (2)

MT-7117 BA and DDI (fasted)

EXPERIMENTAL

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; Drug: PPI; Dietary Supplement: Acidic beverage

MT-7117 food effect and DDI (fed)

EXPERIMENTAL

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; Drug: PPI; Dietary Supplement: Acidic beverage

Interventions

MT-7117 DRUG

MT-7117

MT-7117 BA and DDI (fasted); MT-7117 food effect and DDI (fed)

PPI DRUG

Proton pump inhibitor

MT-7117 BA and DDI (fasted); MT-7117 food effect and DDI (fed)

Acidic beverage DIETARY_SUPPLEMENT

Acidic beverage

MT-7117 BA and DDI (fasted); MT-7117 food effect and DDI (fed)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (1)

Investigational Centre(s)

Germany, Germany

Location

Study Officials

• General Manager

  Mitsubishi Tanabe Pharma Europe Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 27, 2018
• Study Start: October 25, 2018
• Primary Completion: December 22, 2018
• Study Completion: December 22, 2018
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

DE (1)