Mild and Moderate Hepatic ImpairmentPhase 1NCT04116476
Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
A Phase 1 study testing MT-7117 in people with Mild and Moderate Hepatic Impairment, run by Tanabe Pharma America, Inc. at 1 site in United States.
Trial summary
An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild and Moderate Hepatic Impairment
- What is being tested?
- MT-7117
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 16 Feb 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 to 75 years of age inclusive
- BMI 18 -35 kg/m2
- If female, you are nonpregnant, non-lactating and willing to utilize approved methods of birth control.
Who cannot join
- Subjects who have mild or moderate hepatic impairment according to Child-Pugh classification system at Screening (except normal healthy matches)
- Subjects who have a known clinically significant (CS) hypersensitivity to MT-7117 or related compounds, including melatonin.
- Subjects who have previously participated in a study involving MT-7117 or taken any other investigational drug within 30 days or 5 half-lives prior to the first dose of IMP, whichever is longer.
- Subjects who have a CS or unstable neurological, renal, cardiovascular, gastrointestinal, pulmonary, or hematologic disease for 14 days prior to enrollment.
- Subjects who have used any prescription or over-the-counter (OTC) medication within 14 days prior to first dose of IMP, except for occasional use of acetaminophen (< 1 g/day for normal hepatic subjects, and < 2 g/day for hepatically impaired subjects) or any other medication approved by the sponsor (a case-by-case basis). For hepatic impaired subjects, prescribed medication or OTC may be permitted by the Investigator and sponsor on a case-by-case basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Clinical Pharmacology Unit
Miami, Florida, 33136
About this study
Official title: An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects With Normal and Impaired Hepatic Function
An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function
- Conditions
- Mild and Moderate Hepatic Impairment
- Being tested
- MT-7117
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-7117Drug
Single Dose of MT-7117
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: MT-7117 |
| Normal Healthy Matches | Experimental | Not described Receives: Drug: MT-7117 |
| Mild Hepatic Impairment | Experimental | Not described Receives: Drug: MT-7117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of MT-7117
Measured: 0-96 Hours
Area under the plasma concentration time curve from time zero to the time of last quantifiable concentration (AUC0-last) of MT-7117
Measured: 0-96 Hours
Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117
Measured: 0-96 Hours
Secondary outcomes (6)
Time to reach maximum plasma concentration (tmax) of MT-7117
Measured: 0-96 Hours
Plasma terminal elimination half-life (t1/2) of MT-7117
Measured: 0-96 Hours
Apparent oral clearance (CL/F) of MT-7117
Measured: 0-96 Hours
Apparent volume of distribution (Vz/F) of MT-7117
Measured: 0-96 Hours
fraction of unbound drug in plasma or serum (fu) of MT-7117
Measured: 0-96 Hours
Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)
Measured: 0-96 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Aug 2019
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild and Moderate Hepatic ImpairmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Medical Science, Study director, Tanabe Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116476
- Sponsor's protocol ID
- MT-7117-A02
- Status last verified
- May 2023
- First submitted
- 3 Oct 2019
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ogasawara A, Ide R, Inoue S, Teng R, Kawaguchi A. Effect of Hepatic and Renal Impairment on the Pharmacokinetics of Dersimelagon (MT-7117), an Oral Melanocortin-1 Receptor Agonist. Clin Pharmacol Drug Dev. 2024 Jul;13(7):729-738. doi: 10.1002/cpdd.1413. Epub 2024 May 15.
PubMed 38746989
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, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects With Normal and Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT04116476
- Acronym / sponsor ID
- MT-7117-A02
- Conditions
- Mild and Moderate Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 4 Oct 2019 (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, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Drug: MT-7117 |
| Normal Healthy Matches | Experimental | Drug: MT-7117 |
| Mild Hepatic Impairment | Experimental | Drug: MT-7117 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects 18 to 75 years of age inclusive
- BMI 18 -35 kg/m2
- If female, you are nonpregnant, non-lactating and willing to utilize approved methods of birth control.
Key exclusion criteria (5 listed)
- Subjects who have mild or moderate hepatic impairment according to Child-Pugh classification system at Screening (except normal healthy matches)
- Subjects who have a known clinically significant (CS) hypersensitivity to MT-7117 or related compounds, including melatonin.
- Subjects who have previously participated in a study involving MT-7117 or taken any other investigational drug within 30 days or 5 half-lives prior to the first dose of IMP, whichever is longer.
- Subjects who have a CS or unstable neurological, renal, cardiovascular, gastrointestinal, pulmonary, or hematologic disease for 14 days prior to enrollment.
- Subjects who have used any prescription or over-the-counter (OTC) medication within 14 days prior to first dose of IMP, except for occasional use of acetaminophen (< 1 g/day for normal hepatic subjects, and < 2 g/day for hepatically impaired subjects) or any other medication approved by the sponsor (a case-by-case basis). For hepatic impaired subjects, prescribed medication or OTC may be permitted by the Investigator and sponsor on a case-by-case basis.
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-7117Single Dose of MT-7117 | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal Healthy Matches |
Primary outcome
Maximum observed plasma concentration (Cmax) of MT-7117
Time frame: 0-96 Hours
Area under the plasma concentration time curve from time zero to the time of last quantifiable concentration (AUC0-last) of MT-7117
Time frame: 0-96 Hours
Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117
Time frame: 0-96 Hours
6 secondary outcomes
Time to reach maximum plasma concentration (tmax) of MT-7117
Time frame: 0-96 Hours
Plasma terminal elimination half-life (t1/2) of MT-7117
Time frame: 0-96 Hours
Apparent oral clearance (CL/F) of MT-7117
Time frame: 0-96 Hours
Apparent volume of distribution (Vz/F) of MT-7117
Time frame: 0-96 Hours
fraction of unbound drug in plasma or serum (fu) of MT-7117
Time frame: 0-96 Hours
Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: 0-96 Hours
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.
- Derived from this study: PubMed 38746989Ogasawara A, Ide R, Inoue S, Teng R, Kawaguchi A. Effect of Hepatic and Renal Impairment on the Pharmacokinetics of Dersimelagon (MT-7117), an Oral Melanocortin-1 Receptor Agonist. Clin Pharmacol Drug Dev. 2024 Jul;13(7):729-738. doi: 10.1002/cpdd.1413. Epub 2024 May 15.
- Individual participant dataSharing planned: Undecided
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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.
Head of Medical Science study director
Tanabe Pharma America, Inc.
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 in people with Mild and Moderate Hepatic Impairment, run by Tanabe Pharma America, Inc. at 1 site in United States.
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 5 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 United States. 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) of MT-7117 (time frame: 0-96 Hours). 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?
On the ClinicalTrials.gov record for NCT04116476, which also lists 1 linked publication.
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.