MedPath

Elenbecestat

Generic Name
Elenbecestat
Drug Type
Small Molecule
Chemical Formula
C19H18F3N5O2S
CAS Number
1388651-30-6
Unique Ingredient Identifier
RXJ96XL94H
Background

Elenbecestat is under investigation in clinical trial NCT02956486 (A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease).

Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects

Phase 1
Completed
Conditions
Healthy Participants
Interventions
Drug: Placebo
First Posted Date
2017-02-16
Last Posted Date
2017-04-18
Lead Sponsor
Eisai Co., Ltd.
Target Recruit Count
16
Registration Number
NCT03055962
Locations
πŸ‡―πŸ‡΅

Eisai Trial Site, Fukuoka, Japan

A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease

Phase 3
Terminated
Conditions
Alzheimer's Disease
Interventions
Drug: Placebo
First Posted Date
2016-11-06
Last Posted Date
2021-02-03
Lead Sponsor
Eisai Co., Ltd.
Target Recruit Count
2212
Registration Number
NCT02956486
Locations
πŸ‡―πŸ‡΅

Eisai Trial Site 1, Osaka, Japan

πŸ‡¬πŸ‡§

Facility #1, London, United Kingdom

πŸ‡ΊπŸ‡Έ

Facility #11, Miami, Florida, United States

and more 15 locations

A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects

Phase 1
Completed
Conditions
Early Alzheimer's Disease
Interventions
First Posted Date
2016-08-08
Last Posted Date
2017-06-08
Lead Sponsor
Eisai Inc.
Target Recruit Count
32
Registration Number
NCT02859207

Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease

Phase 2
Terminated
Conditions
Alzheimer Disease
Dementia, Alzheimer Type
Interventions
Drug: Placebo
First Posted Date
2014-12-22
Last Posted Date
2021-03-05
Lead Sponsor
Eisai Inc.
Target Recruit Count
70
Registration Number
NCT02322021

A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2014-08-21
Last Posted Date
2015-11-03
Lead Sponsor
Eisai Inc.
Target Recruit Count
60
Registration Number
NCT02222324

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
Drug: Placebo
First Posted Date
2014-08-04
Last Posted Date
2015-11-03
Lead Sponsor
Eisai Inc.
Target Recruit Count
32
Registration Number
NCT02207790

A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2014-02-05
Last Posted Date
2015-11-03
Lead Sponsor
Eisai Inc.
Target Recruit Count
195
Registration Number
NCT02055703
Locations
πŸ‡ΊπŸ‡Έ

WCT Early Development, San Antonio, Texas, United States

An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects

Phase 1
Completed
Conditions
Metabolism and Elimination
Interventions
First Posted Date
2013-11-05
Last Posted Date
2016-01-08
Lead Sponsor
Eisai Inc.
Target Recruit Count
113
Registration Number
NCT01975636
Locations
πŸ‡ΊπŸ‡Έ

Covance Clinical Research Unit Inc., Madison, Wisconsin, United States

πŸ‡ΊπŸ‡Έ

Covance Laboratories, Madison, Wisconsin, United States

An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption

Phase 1
Completed
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2012-10-30
Last Posted Date
2013-05-22
Lead Sponsor
Eisai Inc.
Target Recruit Count
18
Registration Number
NCT01716897
Locations
πŸ‡ΊπŸ‡Έ

California Clinical Trials/Parexel, Glendale, California, United States

Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)

Phase 1
Completed
Conditions
Alzheimer's Disease
Interventions
Drug: Placebo for E2609
First Posted Date
2012-05-17
Last Posted Date
2016-12-30
Lead Sponsor
Eisai Inc.
Target Recruit Count
65
Registration Number
NCT01600859
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