CLINICAL TRIALS PROFILE FOR MT-7117

Clinical Trials for MT-7117

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02834442 ↗	A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects	Completed	Mitsubishi Tanabe Pharma Corporation	Phase 1	The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.
NCT03503266 ↗	Mass Balance Study With MT-7117	Completed	Mitsubishi Tanabe Pharma Development America, Inc.	Phase 1	This is a single-centre, open-label, mass balance study in healthy male subjects utilising a single oral dose of [14C] MT 7117.
NCT03520036 ↗	Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria	Completed	Mitsubishi Tanabe Pharma Development America, Inc.	Phase 2	The purpose of this study is to investigate the efficacy and safety of MT-7117 on sunlight exposure duration without symptoms and tolerance in subjects with EPP.
NCT03688022 ↗	Relative Bioavailability and Drug-drug Interaction Study With MT-7117 and a Proton Pump Inhibitor	Completed	Mitsubishi Tanabe Pharma Development America, Inc.	Phase 1	An open label, multicentre, randomised, 2-cohort, sequential and crossover study to assess the relative oral bioavailability of MT-7117 higher content tablets versus MT-7117 lower content tablets and the pharmacokinetics of MT-7117 under various gastric conditions (fed and fasted, and following administration of a proton pump inhibitor and an acidic beverage) in healthy subjects
NCT04116476 ↗	Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function	Completed	Mitsubishi Tanabe Pharma Development America, Inc.	Phase 1	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
NCT04402489 ↗	Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoetic Protoporphyria or X-Linked Protoporphyria	Active, not recruiting	Mitsubishi Tanabe Pharma Development America, Inc.	Phase 3	The primary objective of this study is to investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, or stinging) associated with sunlight exposure in subjects with EPP or XLP aged 12-75.
NCT04440592 ↗	Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis	Recruiting	Mitsubishi Tanabe Pharma Development America, Inc.	Phase 2	To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52

Clinical Trial Conditions for MT-7117

Condition Name

Condition Name
Intervention	Trials
EPP	2
Erythropoietic Protoporphyria (EPP)	2
Healthy Subjects	2
Healthy Volunteer	2

Condition MeSH

Condition MeSH
Intervention	Trials
Protoporphyria, Erythropoietic	4
Renal Insufficiency	1
Sclerosis	1
Scleroderma, Systemic	1

Clinical Trial Locations for MT-7117

Trials by Country

Trials by Country
Location	Trials
United States	57
Germany	10
United Kingdom	9
Japan	8
Italy	7

Trials by US State

Trials by US State
Location	Trials
Texas	7
Florida	7
Ohio	5
Massachusetts	5
California	5

Clinical Trial Progress for MT-7117

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	2
Phase 1	7

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	6
Completed	5
Active, not recruiting	1

Clinical Trial Sponsors for MT-7117

Sponsor Name

Sponsor Name
Sponsor	Trials
Mitsubishi Tanabe Pharma Development America, Inc.	10
Mitsubishi Tanabe Pharma Corporation	1
Mitsubishi Tanabe Pharma America Inc.	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	12