PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function

NCT04656795 | Completed Phase 1 FDA Drug

• 2 other identifiers: MT-7117-Z-1012020-003333-38
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax) of MT-7117

  Day 1 to 4

• Area under the plasma concentration time curve from time zero to the last quantifiable concentration (AUC0-last) of MT-7117

  Day 1 to 4

• Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117

  Day 1 to 4

Secondary Outcomes (9)

• Safety and tolerability as measured by incidence of Treatment emergent adverse events

  Day -1 to Day 8

• Time to maximum plasma concentration (tmax) of MT-7117

  Day 1 to 4

• Apparent elimination half-time of MT-7117 in plasma (t1/2)

  Day 1 to 4

• Apparent oral clearance (CL/F) of MT-7117in plasma

  Day 1 to 4

• Apparent volume of distribution during the terminal phase (Vz/F) of MT-7117in plasma

  Day 1 to 4

Study Arms (4)

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

Interventions

MT-7117 DRUG

MT-7117

Also known as: dersimelagon

Subjects with mild renal impairment; Subjects with moderate renal impairment; Subjects with normal renal function; Subjects with severe renal impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (1)

Clinical Research Services (CRS) Kiel GmbH

Kiel, Germany

Location

Related Publications (1)

• 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.

  PMID: 38746989 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 7, 2020
• Study Start: December 2, 2020
• Primary Completion: December 4, 2021
• Study Completion: December 9, 2021
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)