Renal ImpairmentPhase 1NCT04656795
PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function
A Phase 1 study testing MT-7117 in people with Renal Impairment and Normal Renal Function, run by Tanabe Pharma America, Inc. at 1 site in Germany.
Trial summary
This is an open-label, non randomised, single-dose, study in male and female subjects with renal impairment (severe and if required mild \& moderate) compared to male and female subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Normal Renal Function
- What is being tested?
- MT-7117
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 2 Dec 2020to 9 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A subject will be eligible for enrolment in the study if ALL of the following criteria apply:
- For Groups 1, 2, 3 and 4
- Subject is able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form (ICF) and after having the opportunity to discuss the study with the Investigator or designee.
- Male or female subjects, ≥ 18 to 80 years of age (inclusive), at the time of signing the ICF.
- In the Investigator's opinion, subject is able to understand the nature of the study and all risks involved with participation in the study and willing to cooperate and comply with all Protocol restrictions and requirements.
- Subjects must weigh at least 50 kg (110 pounds) and have a body mass index 18 to 35 kg/m2 both inclusive at Screening and on Day -1.
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- The subject's vital signs must be within the reference range for their age at Screening and on Day 1. Subjects must have rested for at least 5 minutes in a supine position prior to collecting blood pressure and pulse. In subjects with normal renal function, normal blood pressure is considered in the range of 90 to 145 mmHg for systolic blood pressure (SBP) and 50 to 95 mmHg for diastolic blood pressure (DBP). In subjects with renal impairment, normal blood pressure is considered in the range of 90 to 179 mmHg for SBP and 50 to 105 mmHg for DBP. Pulse rate should be between 50 to 100 beats per minutes.
- Female subjects must not be lactating and must have a negative serum pregnancy test at Screening and on Day 1.
- Female subjects of child bearing potential and male subjects with a partner of child bearing potential must agree to use 2 effective methods of contraception (in female subjects, one method must be highly effective.
- For Group 1 (Subjects with Normal Renal Function)
- Subjects must have an absolute eGFR of ≥ 90 mL/min, as determined by the MDRD equation, multiplied by the individual BSA according to the DuBois \& DuBois equation and divided by 1.73 m2 at Screening and confirmed at Day 1 (admission to the study centre).
- Subjects must be in good health and free from clinically significant illness or disease in the opinion of the Investigator based upon the results of medical history, physical examination, clinical laboratory tests (biochemistry, haematology, coagulation and urinalysis), vital signs and a 12 lead electrocardiogram (ECG) at Screening and Day -1.
- Subjects with normal renal function (Group 1) will be matched in pairs by race, age (± 10 years of subject in Group 4), weight (± 10 kg of the subject in Group 4), gender and smoking status to subjects with severe renal impairment (Group 4).
- For Groups 2 to 4 (Subjects with Renal Impairment)
- Subjects must have stable renal impairment based on medical history, physical examination and clinical laboratory results. Stable renal impairment is defined as no clinically significant change in an eGFR within 3 months or longer prior to study Screening, as determined by the Investigator.
- Subjects with renal impairment must have the following absolute eGFR values as determined by the MDRD equation, multiplied by the individual BSA according to the DuBois \& DuBois equation and divided by 1.73 m2 at Screening and confirmed at Day 1 (admission to the study centre) Group 2: Mild renal impairment must have an absolute eGFR of ≥ 60 to < 90 mL/min Group 3: Moderate renal impairment must have an absolute eGFR of ≥ 30 to < 60 mL/min Group 4: Severe renal impairment must have an absolute eGFR of < 30 mL/min; not on dialysis
- Subjects must have acceptable clinical conditions in the opinion of the Investigator based upon the results of medical history, physical examination, clinical laboratory tests (biochemistry, haematology, coagulation and urinalysis), vital signs and a 12 lead ECG at Screening and Day -1.
- The age of subjects in Groups 2 and 3 must not be more than 10 years younger than the youngest subject in Group 1 or more than 10 years older than the oldest subject in Group 1. The weight of subjects in Groups 2 and 3 must not be more than 20% lighter than the lightest subject in Group 1 or more than 20% heavier than the heaviest subject in Group 1.
- Subjects with mild renal impairment (Group 2) and moderate renal impairment (Group 3) will be matched by race, age, weight and gender to subjects in Group 1 (age and weight are to be matched as per inclusion criterion 4 above. It is not necessary to match subjects between Groups 2 and 3 and Group 1 in pairs, but there must be the same number of each gender and each race in each of Groups 2 and 3 as there are in Group 1).
Who cannot join
- A subject will NOT be eligible for this study if ANY of the following criteria apply:
- For Groups 1, 2, 3 and 4
- Subjects who have a known clinically significant hypersensitivity to MT-7117 or related compounds (or relevant excipients). Subjects who have a history of clinically significant hypersensitivity, intolerance, allergy or anaphylaxis to any drug compound, food or other substance unless approved by the Investigator and the Sponsor.
- Subjects who are currently on dialysis.
- Subjects who have any active malignancy (including melanoma but excluding basal cell carcinoma) or history of significant malignancy (including melanoma).
- Subjects who have previously participated in a study involving MT-7117 within 6 months prior to the first dose of Investigational Medicinal Product (IMP) and/or subjects who have previously taken any other investigational drug within 2 months or 5 half-lives prior to the first dose of IMP, whichever is longer.
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- A history or presence of clinically significant neurological, haematological, psychiatric, gastrointestinal (including cholecystectomy), pulmonary or hepatic disease or other condition (with the exception of renal insufficiency for Groups 2 to 4) known to interfere with the absorption, distribution, metabolism or excretion of drugs or any condition which could place the subjects at increased risk as determined by the Investigator.
- Clinically significant 12-lead ECG abnormalities, including subjects with corrected QT interval using Fridericia's formula (QTcF) of > 450 ms (male) and > 470 ms (female), at Screening or Day -1, confirmed by repeat assessment.
- Subject takes non-permitted concomitant medication within 28 days (or 5 half lives of the drug, whichever is longer) of dosing on Day 1. Subjects with normal renal function are restricted from use of any concomitant medications unless discussed and agreed with the Sponsor. For renal impaired subjects, prescribed medication or over the counter (OTC) medication for treating underlying disease states or chronic medical conditions or disorders related to renal impairment are permitted as described in the protocol. If subjects with renal impairment are on any medication not listed in the protocol, this must be discussed with the Sponsor on a case-by-case basis, prior to the subject's inclusion in the study.
- Subjects who have a positive drug screen at Screening or Day 1 (admission to the study centre), unless the positive drug screen is due to prescription drug use that is approved by the Investigator and the Sponsor.
- Subjects who have a positive human immunodeficiency virus (HIV) antibody at Screening. Consent and counselling for this procedure will be performed according to the site's Standard Operating Procedures.
- Subjects who have a positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb) at Screening.
- Acute illness or infection, minor surgical procedures or trauma from within 2 weeks before Screening until administration of study drug.
- Subjects who have a history of kidney, other organ or bone marrow transplant.
- Subjects who have a history of major surgery within 3 months before Day 1.
- Subjects who have a history of long QT syndrome or cardiac brady-tachy-arrhythmia.
- Donation of 1 or more units of blood (≥ 450 mL) in the 3 months prior to Screening or plasma in the 7 days prior to Screening or platelets in the 6 weeks prior to Screening or intention to donate blood within 3 months after the final follow-up assessment.
- Subjects who have consumed liquorice, grapefruit or grapefruit juice, orange or their associated products, within 7 days prior to study treatment on Day 1.
- Subjects who are smokers or use tobacco or nicotine containing products (snuff, chewing tobacco, cigarettes, cigars, pipes, e-cigarettes or nicotine replacement products) and currently smoke more than 10 cigarettes or equivalent per day or are unable or unwilling to stop from 4 hours pre-dose until 6 hours post dose.
- Subjects who are not willing to abstain from consumption of caffeine and methylxanthine (e.g., coffee, tea, cola, energy drinks or chocolates) in the 36 hours before Day 1 until completion of the post-treatment assessments on Day 4 and in the 36 hours before the Follow-up/EoS Visit on Day 8.
- Subjects who regularly, or on average, drink more than 21 units (168 g) for males or 14 units (112 g) for females, of alcohol per week (1 unit is equivalent to 8g of alcohol).
- Subjects with any other condition or reason that, in the opinion of the Investigator or Sponsor, would make the subject unsuitable for enrolment.
- Subjects who test positive for Coronavirus Disease 2019 at Screening or Day -1.
- Subject with the presence of a skin lesion suspicious for dysplastic naevus or a history of histologically proven dysplastic naevus.
- Group 1 (Subjects with Normal Renal Function):
- Subjects with aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT) or total bilirubin level (TBL) > 1.5 times upper limit of normal (ULN) during Screening or at Day 1.
- For Groups 2, 3 and 4 (Subjects with Renal Impairment)
- Use of concurrent medications, which affect the eGFR such as cephalosporin antibiotics, ascorbic acid, trimethoprim, cimetidine or quinine for at least 28 days prior to Day 1 (or 5 half-lives of the drug, whichever is longer).
- Subject who has renal disease secondary to malignancy.
- Subjects with acute renal failure.
- Subject with any of the liver function test (AST, ALT, ALP and TBL) out of the following range (TBL > 1.5 × ULN, ALT and AST > 2 × ULN and ALP > 3 × ULN) at Screening or Day -1.
- Subjects have serum albumin < 30 g/L and haemoglobin < 8 g/dL
- Subject has not been on a stable dose of concomitant medications for the previous 28 days and/or has started new medications to treat concurrent chronic conditions in the previous 28 days (or 5 half lives of the drug, whichever is longer) prior to IMP dosing. Minor dose adjustments to the subject's regular medication may be allowed up to 14 days prior to IMP dosing after consultation with the Sponsor. This medication regimen should not change whilst the subject is enrolled in the study.
- Any clinically significant abnormalities, other than those associated with the subject's degree of renal impairment, in biochemistry, haematology, coagulation and urinalysis results as judged by the Investigator and the Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Non-Randomized, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of MT-7117 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
This is an open-label, non randomised, single-dose, study in male and female subjects with renal impairment (severe and if required mild \& moderate) compared to male and female subjects with normal renal function.
- Conditions
- Renal Impairment, Normal Renal Function
- Being tested
- MT-7117
- Keywords
- PK Study in subjects with renal impairment (severe and if required mild & moderate) vs. subjects with normal renal function
- Medical subject headings
- Renal Insufficiency, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-7117Drug
Also called dersimelagon
MT-7117
| Study group | Role | What they receive |
|---|---|---|
| Subjects with severe renal impairment | Experimental | Not described Receives: Drug: MT-7117 |
| Subjects with normal renal function | Experimental | Not described Receives: Drug: MT-7117 |
| Subjects with moderate renal impairment | Experimental | Not described Receives: Drug: MT-7117 |
| Subjects with mild renal 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: Day 1 to 4
Area under the plasma concentration time curve from time zero to the last quantifiable concentration (AUC0-last) of MT-7117
Measured: Day 1 to 4
Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117
Measured: Day 1 to 4
Secondary outcomes (9)
Safety and tolerability as measured by incidence of Treatment emergent adverse events
Measured: Day -1 to Day 8
Time to maximum plasma concentration (tmax) of MT-7117
Measured: Day 1 to 4
Apparent elimination half-time of MT-7117 in plasma (t1/2)
Measured: Day 1 to 4
Apparent oral clearance (CL/F) of MT-7117in plasma
Measured: Day 1 to 4
Apparent volume of distribution during the terminal phase (Vz/F) of MT-7117in plasma
Measured: Day 1 to 4
Unbound fraction (fu) of MT-7117 in plasma
Measured: Day 1 to 4
Maximum observed unbound plasma concentration (Cmax,u) of MT-7117 of MT-7117
Measured: Day 1 to 4
Area under the unbound plasma concentration time curve from time zero to the last quantifiable concentration (AUC0-last, u) of MT-7117
Measured: Day 1 to 4
Area under the unbound plasma concentration time curve from time zero to infinity (AUC0-∞, u)of MT-7117
Measured: Day 1 to 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start2 Dec 2020
- Primary completion4 Dec 2021
- Study completion9 Dec 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 Renal 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT04656795
- Sponsor's protocol ID
- MT-7117-Z-101
- Other IDs
- 2020-003333-38
- Status last verified
- May 2023
- First submitted
- 23 Nov 2020
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Single Dose, Non-Randomized, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of MT-7117 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT04656795
- Acronym / sponsor ID
- MT-7117-Z-101
- Conditions
- Renal Impairment, Normal Renal Function
- Keywords
- PK Study in subjects with renal impairment (severe and if required mild & moderate) vs. subjects with normal renal function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 4 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 7 Dec 2020 (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.
This is an open-label, non randomised, single-dose, study in male and female subjects with renal impairment (severe and if required mild \& moderate) compared to male and female subjects with normal renal function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| Subjects with severe renal impairment | Experimental | Drug: MT-7117 |
| Subjects with normal renal function | Experimental | Drug: MT-7117 |
| Subjects with moderate renal impairment | Experimental | Drug: MT-7117 |
| Subjects with mild renal impairment | Experimental | Drug: MT-7117 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- A subject will be eligible for enrolment in the study if ALL of the following criteria apply:
- For Groups 1, 2, 3 and 4
- Subject is able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form (ICF) and after having the opportunity to discuss the study with the Investigator or designee.
- Male or female subjects, ≥ 18 to 80 years of age (inclusive), at the time of signing the ICF.
- In the Investigator's opinion, subject is able to understand the nature of the study and all risks involved with participation in the study and willing to cooperate and comply with all Protocol restrictions and requirements.
Key exclusion criteria (34 listed)
- A subject will NOT be eligible for this study if ANY of the following criteria apply:
- For Groups 1, 2, 3 and 4
- Subjects who have a known clinically significant hypersensitivity to MT-7117 or related compounds (or relevant excipients). Subjects who have a history of clinically significant hypersensitivity, intolerance, allergy or anaphylaxis to any drug compound, food or other substance unless approved by the Investigator and the Sponsor.
- Subjects who are currently on dialysis.
- Subjects who have any active malignancy (including melanoma but excluding basal cell carcinoma) or history of significant malignancy (including melanoma).
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-7117Also: dersimelagonMT-7117 | Drug | Subjects with mild renal impairment, Subjects with moderate renal impairment, Subjects with normal renal function, Subjects with severe renal impairment |
Primary outcome
Maximum observed plasma concentration (Cmax) of MT-7117
Time frame: Day 1 to 4
Area under the plasma concentration time curve from time zero to the last quantifiable concentration (AUC0-last) of MT-7117
Time frame: Day 1 to 4
Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117
Time frame: Day 1 to 4
9 secondary outcomes
Safety and tolerability as measured by incidence of Treatment emergent adverse events
Time frame: Day -1 to Day 8
Time to maximum plasma concentration (tmax) of MT-7117
Time frame: Day 1 to 4
Apparent elimination half-time of MT-7117 in plasma (t1/2)
Time frame: Day 1 to 4
Apparent oral clearance (CL/F) of MT-7117in plasma
Time frame: Day 1 to 4
Apparent volume of distribution during the terminal phase (Vz/F) of MT-7117in plasma
Time frame: Day 1 to 4
Unbound fraction (fu) of MT-7117 in plasma
Time frame: Day 1 to 4
Maximum observed unbound plasma concentration (Cmax,u) of MT-7117 of MT-7117
Time frame: Day 1 to 4
Area under the unbound plasma concentration time curve from time zero to the last quantifiable concentration (AUC0-last, u) of MT-7117
Time frame: Day 1 to 4
Area under the unbound plasma concentration time curve from time zero to infinity (AUC0-∞, u)of MT-7117
Time frame: Day 1 to 4
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: No
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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 Renal Impairment and Normal Renal Function, 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 19 inclusion and 34 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) of MT-7117 (time frame: Day 1 to 4). 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 NCT04656795, 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.