Healthy VolunteerPhase 1MT-7117 BA DDINCT03688022
Relative Bioavailability and Drug-drug Interaction Study With MT-7117 and a Proton Pump Inhibitor
A Phase 1 study testing MT-7117, PPI and Acidic beverage in people with Healthy Volunteer, run by Tanabe Pharma America, Inc. at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MT-7117, PPI and Acidic beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 25 Oct 2018to 22 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- MT-7117, PPI, Acidic beverage
- Keywords
- Relative Bioavailability and DDI study with MT-7117 and a proton pump inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-7117Drug
MT-7117
PPIDrug
Proton pump inhibitor
Acidic beverageDietary supplement
Acidic beverage
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: MT-7117; Drug: PPI; Dietary Supplement: Acidic beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: Pre-dose and up to 48 hours following each single dose
Secondary outcomes (1)
Incidence of adverse events (AEs) and serious AEs
Measured: up to 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start25 Oct 2018
- Primary completion22 Dec 2018
- Study completion22 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Mitsubishi Tanabe Pharma Europe Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688022
- Sponsor's protocol ID
- MT-7117-E03
- Other IDs
- 2018-002718-11, 2018
- Acronym
- MT-7117 BA DDI
- Status last verified
- May 2023
- First submitted
- 18 Sep 2018
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03688022
- Acronym / sponsor ID
- MT-7117 BA DDI / MT-7117-E03
- Conditions
- Healthy Volunteer
- Keywords
- Relative Bioavailability and DDI study with MT-7117 and a proton pump inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 22 Dec 2018 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| MT-7117 BA and DDI (fasted) | Experimental | Drug: MT-7117, Drug: PPI, Dietary Supplement: Acidic beverageMT-7117 lower content tablets, higher content tablets, higher content tablets with PPI (fasted), higher content tablets with PPI and acidic beverage (fasted) |
| MT-7117 food effect and DDI (fed) | Experimental | Drug: MT-7117, Drug: PPI, Dietary Supplement: Acidic beverageMT-7117 higher content tablets (fasted and fed), higher content tablets with PPI (fed), higher content tablets with PPI and acidic beverage (fed) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-7117MT-7117 | Drug | MT-7117 BA and DDI (fasted), MT-7117 food effect and DDI (fed) |
| PPIProton pump inhibitor | Drug | MT-7117 BA and DDI (fasted), MT-7117 food effect and DDI (fed) |
| Acidic beverageAcidic beverage | Dietary supplement | MT-7117 BA and DDI (fasted), MT-7117 food effect and DDI (fed) |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: Pre-dose and up to 48 hours following each single dose
1 secondary outcome
Incidence of adverse events (AEs) and serious AEs
Time frame: up to 48 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Mitsubishi Tanabe Pharma Europe Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-7117, PPI and Acidic beverage in people with Healthy Volunteer, run by Tanabe Pharma America, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Pre-dose and up to 48 hours following each single dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.