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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688022
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open 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 : October 25, 2018
Actual Primary Completion Date : December 22, 2018
Actual Study Completion Date : December 22, 2018

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




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Pre-dose and up to 48 hours following each single dose ]
  2. Area under the plasma concentration time curve from time zero to last quantifiable concentration (AUC0-t) [ Time Frame: Pre-dose and up to 48 hours following each single dose ]
  3. Area under the plasma concentration time curve from time zero to infinity (AUC0-inf) [ Time Frame: Pre-dose and up to 48 hours following each single dose ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) and serious AEs [ Time Frame: up to 48 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688022


Locations
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Germany
Investigational Centre(s)
Germany, Germany
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Europe Ltd
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Responsible Party: Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier: NCT03688022    
Other Study ID Numbers: MT-7117-E03
2018-002718-11 ( EudraCT Number )
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mitsubishi Tanabe Pharma Development America, Inc.:
Relative Bioavailability and DDI study with MT-7117 and a proton pump inhibitor