HealthyPhase 1NCT02953132

A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers

A Phase 1 study testing MT-4129 in people with Healthy, run by Tanabe Pharma Corporation at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: MT-4129
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 1 siteNetherlands
Study dates: Nov 2016to May 2017
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy and free from clinically significant illness or disease
Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2

Who cannot join

Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, neurological, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
Clinically relevant abnormal medical history, physical findings or laboratory values

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Pharmaceutical Research Associates (PRA) Health Sciences
City Name

Other trials in Netherlands

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-4129 in Healthy Subjects; Including the Effect of Gender and Age on the Pharmacokinetics of a Single Dose of MT-4129 in Healthy Subjects

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects.

Conditions: Healthy
Being tested: MT-4129, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MT-4129Drug
PlaceboDrug

Study groups in NCT02953132
Study group	Role	What they receive
Single ascending dose, MT-4129 or Placebo	Experimental	Not described Receives: Drug: MT-4129; Drug: Placebo
Multiple ascending dose, MT-4129 or Placebo	Experimental	Not described Receives: Drug: MT-4129; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability as measured by incidence and severity of adverse events
Measured: Up to Day 14
Safety and Tolerability as measured by vital signs
Measured: Up to Day 14
Safety and Tolerability as measured by ECG
Measured: Up to Day 14
Safety and Tolerability as measured by clinical laboratory assessments
Measured: Up to Day 14
Safety and Tolerability as measured by Hormone assessments
Measured: Up to Day 10
Safety and Tolerability as measured by physical examination
Measured: Up to Day 14

Secondary outcomes (24)

Maximum observed plasma concentration (Cmax) of MT-4129
Measured: Up to Day 10
Measured time of maximum observed plasma concentration (tmax) of MT-4129
Measured: Up to Day 10
Apparent terminal elimination half-life (t1/2) of MT-4129
Measured: Up to Day 10
AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129
Measured: Up to Day 8
AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129
Measured: Up to Day 9
AUC from time zero to 72 hours post-dose (AUC0-72) of MT-4129
Measured: Up to Day 10
AUC from time zero to infinity (AUC0-∞) of MT-4129
Measured: Up to Day 10
AUC from time zero to the last measurable concentration (AUC0-last) of MT-4129
Measured: Up to Day 10
AUC over the dosing interval (AUC0-t) of MT-4129
Measured: Up to Day 10
Terminal elimination rate constant (Kel) of MT-4129
Measured: Up to Day 10
Mean residence time (MRT) of MT-4129
Measured: Up to Day 10
Apparent volume of distribution during terminal phase after oral administration (Vz/F) of MT-4129
Measured: Up to Day 10
Apparent volume of distribution at steady state (Vss/F) of MT-4129
Measured: Up to Day 10
Apparent oral clearance (CL/F) of MT-4129
Measured: Up to Day 10
Urinary excreted amount of test compound (Ae) of MT-4129
Measured: Up to Day 10
Urinary excreted amount of test compound expressed as a percentage of the dose administered (Ae%) of MT-4129
Measured: Up to Day 10
Renal clearance (CLR) of MT-4129
Measured: Up to Day 10
Plasma aldosterone
Measured: Up to Day 10
Serum cortisol
Measured: Up to Day 10
Plasma steroid hormones
Measured: Up to Day 10
Urinary aldosterone
Measured: Up to Day 10
Urinary cortisol
Measured: Up to Day 10
Urinary sodium
Measured: Up to Day 10
Urine potassium
Measured: Up to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016May 2017

First posted2 Nov 2016 (estimated)
Study startNov 2016
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: Parallel groups
Masking: Double blind
Enrolment: 116 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02953132
Sponsor's protocol ID: MT-4129-E01
Status last verified: May 2017
First submitted: 31 Oct 2016
Last updated: 18 May 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-4129 in Healthy Subjects; Including the Effect of Gender and Age on the Pharmacokinetics of a Single Dose of MT-4129 in Healthy Subjects
ClinicalTrials.gov ID: NCT02953132
Acronym / sponsor ID: MT-4129-E01
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (estimated)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2016
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 2 Nov 2016 (estimated)
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.

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Single ascending dose, MT-4129 or Placebo	Experimental	Drug: MT-4129, Drug: Placebo
Multiple ascending dose, MT-4129 or Placebo	Experimental	Drug: MT-4129, Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy and free from clinically significant illness or disease
Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2

Key exclusion criteria (3 listed)

Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, neurological, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
Clinically relevant abnormal medical history, physical findings or laboratory values

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-4129	Drug	Multiple ascending dose, MT-4129 or Placebo, Single ascending dose, MT-4129 or Placebo
Placebo	Drug	Multiple ascending dose, MT-4129 or Placebo, Single ascending dose, MT-4129 or Placebo

Primary outcome

Safety and Tolerability as measured by incidence and severity of adverse events
Time frame: Up to Day 14
Safety and Tolerability as measured by vital signs
Time frame: Up to Day 14
Safety and Tolerability as measured by ECG
Time frame: Up to Day 14
Safety and Tolerability as measured by clinical laboratory assessments
Time frame: Up to Day 14
Safety and Tolerability as measured by Hormone assessments
Time frame: Up to Day 10
Safety and Tolerability as measured by physical examination
Time frame: Up to Day 14

24 secondary outcomes

Maximum observed plasma concentration (Cmax) of MT-4129
Time frame: Up to Day 10
Measured time of maximum observed plasma concentration (tmax) of MT-4129
Time frame: Up to Day 10
Apparent terminal elimination half-life (t1/2) of MT-4129
Time frame: Up to Day 10
AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129
Time frame: Up to Day 8
AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129
Time frame: Up to Day 9
AUC from time zero to 72 hours post-dose (AUC0-72) of MT-4129
Time frame: Up to Day 10
AUC from time zero to infinity (AUC0-∞) of MT-4129
Time frame: Up to Day 10
AUC from time zero to the last measurable concentration (AUC0-last) of MT-4129
Time frame: Up to Day 10
AUC over the dosing interval (AUC0-t) of MT-4129
Time frame: Up to Day 10
Terminal elimination rate constant (Kel) of MT-4129
Time frame: Up to Day 10
Mean residence time (MRT) of MT-4129
Time frame: Up to Day 10
Apparent volume of distribution during terminal phase after oral administration (Vz/F) of MT-4129
Time frame: Up to Day 10
Apparent volume of distribution at steady state (Vss/F) of MT-4129
Time frame: Up to Day 10
Apparent oral clearance (CL/F) of MT-4129
Time frame: Up to Day 10
Urinary excreted amount of test compound (Ae) of MT-4129
Time frame: Up to Day 10
Urinary excreted amount of test compound expressed as a percentage of the dose administered (Ae%) of MT-4129
Time frame: Up to Day 10
Renal clearance (CLR) of MT-4129
Time frame: Up to Day 10
Plasma aldosterone
Time frame: Up to Day 10
Serum cortisol
Time frame: Up to Day 10
Plasma steroid hormones
Time frame: Up to Day 10
Urinary aldosterone
Time frame: Up to Day 10
Urinary cortisol
Time frame: Up to Day 10
Urinary sodium
Time frame: Up to Day 10
Urine potassium
Time frame: Up to Day 10

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 18 May 2017.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
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Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
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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

Tanabe Pharma Corporation

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-4129 in people with Healthy, run by Tanabe Pharma Corporation at 1 site in Netherlands.

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 3 inclusion and 3 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 18 May 2017. 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 Netherlands. 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?

Safety and Tolerability as measured by incidence and severity of adverse events (time frame: Up to Day 14). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953132.

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 18 May 2017.