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

COMPLETEDPHASE1

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

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

NCT04656795•Tanabe Pharma America, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•A subject will be eligible for enrolment in the study if ALL of the following criteria apply:
•For Groups 1, 2, 3 and 4
•1. 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.
•2. Male or female subjects, ≥ 18 to 80 years of age (inclusive), at the time of signing the ICF.
•3. 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.
•4. 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.
•5. 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.
•6. Female subjects must not be lactating and must have a negative serum pregnancy test at Screening and on Day 1.
•7. 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)
+9 more criteria

Exclusion Criteria

•A subject will NOT be eligible for this study if ANY of the following criteria apply:
•For Groups 1, 2, 3 and 4
•1. 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.
•2. Subjects who are currently on dialysis.
•3. Subjects who have any active malignancy (including melanoma but excluding basal cell carcinoma) or history of significant malignancy (including melanoma).
•4. 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.
•5. 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.
•6. 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.
•7. 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.
•8. 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.
+24 more criteria

Locations (1)

Clinical Research Services (CRS) Kiel GmbH

Kiel, Germany

Key Dates

Start Date

December 2, 2020

Primary Completion Date

December 4, 2021

Completion Date

December 9, 2021

Last Updated

May 15, 2023

Enrollment

ACTUAL participants

Conditions

Renal ImpairmentNormal Renal Function

Interventions

MT-7117

DRUG

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Renal Impairment

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ACTIVE_NOT_RECRUITINGPHASE1

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Renal ImpairmentHealthy+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure