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.

Clinical Trial Conditions for MT-7117

Condition Name

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

Condition MeSH

Condition MeSH
Intervention	Trials
Protoporphyria, Erythropoietic	4
Scleroderma, Systemic	1
Scleroderma, Diffuse	1
Genetic Diseases, X-Linked	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