NCT04656795 is a Phase 1 clinical trial of MT-7117 in Renal Impairment, sponsored by Tanabe Pharma America, Inc..

Who is sponsoring NCT04656795?

NCT04656795 is sponsored by Tanabe Pharma America, Inc..

What drugs are being tested in NCT04656795?

Interventions in NCT04656795: MT-7117.

What condition does NCT04656795 study?

NCT04656795 studies Renal Impairment, Normal Renal Function.

Is NCT04656795 still recruiting?

NCT04656795 is currently completed. Last updated 15 May 2023.

Last reviewed 2023-05-15 · How we verify

NCT04656795

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 15 May 2023

What this trial tests

Phase 1 trial testing MT-7117 in Renal Impairment in 32 participants. Completed in 9 December 2021.

Timeline

2 December 2020

Primary endpoint
4 December 2021

9 December 2021

Quick facts

Lead sponsor	Tanabe Pharma America, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	32
Start date	2 December 2020
Primary completion	4 December 2021
Estimated completion	9 December 2021
Sites	1 location across Germany

Drugs / interventions tested

MT-7117 — full drug profile →

Conditions studied

Renal Impairment — all drugs for Renal Impairment →
Normal Renal Function — all drugs for Normal Renal Function →

Sponsor

Tanabe Pharma America, Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Renal Impairment or Normal Renal Function. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Physiologically based pharmacokinetic modelling to predict potential drug-drug interactions of dersimelagon (MT-7117).
Ogasawara A, Kojima K, Murata Y, Shimizu H. · · 2025 · cited 1× · PMID 39367654 · DOI 10.1111/bcp.16271
Effect of Hepatic and Renal Impairment on the Pharmacokinetics of Dersimelagon (MT-7117), an Oral Melanocortin-1 Receptor Agonist.
Ogasawara A, Ide R, Inoue S, Teng R, et al · · 2024 · cited 1× · PMID 38746989 · DOI 10.1002/cpdd.1413

Verify or expand the search:

Other trials of MT-7117

Trials testing the same drug.

NCT06994286 — The Purpose of This Study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects · Phase 1 · completed
NCT05241535 — Study to Evaluate the Effect of a Single Oral Dose of MT-7117 on the QT/QTc Interval in Healthy Subjects · Phase 1 · completed
NCT04793295 — Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects · Phase 1 · completed
NCT04440592 — Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis · Phase 2 · completed
NCT04116476 — Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Funct · Phase 1 · completed

Other recruiting trials for Renal Impairment

Currently open trials in the same condition.

NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · recruiting

Other Tanabe Pharma America, Inc. trials

Trials by the same sponsor.

NCT05241535 — Study to Evaluate the Effect of a Single Oral Dose of MT-7117 on the QT/QTc Interval in Healthy Subjects · Phase 1 · completed
NCT05151471 — Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS · Phase 3 · terminated
NCT04683848 — Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury · Phase 2 · completed
NCT04793295 — Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects · Phase 1 · completed
NCT04440592 — Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04656795 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tanabe Pharma America, Inc.
Last refreshed: 15 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04656795.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing