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Placebo (Part 1)

DRUG4 trials

Sponsors

Merck Sharp & Dohme LLC, Tetherex Pharmaceuticals Corporation, Enanta Pharmaceuticals, Inc, Food and Drug Administration (FDA)

Conditions

Alzheimer's DiseaseAmnestic Mild Cognitive ImpairmentAsthmaChronic Hepatitis B Virus InfectionChronic Obstructive Pulmonary DiseaseDrug-induced QT ProlongationPharmacodynamicsPharmacokinetics

Phase 1

A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
TerminatedNCT04971512
Enanta Pharmaceuticals, IncChronic Hepatitis B Virus Infection
Start: 2021-08-02End: 2021-12-20Updated: 2022-02-14
Electrophysiological Effects of Potential QT Prolonging Drugs
CompletedNCT05716854
Food and Drug Administration (FDA)Drug-induced QT Prolongation, Pharmacodynamics, Pharmacokinetics
Start: 2023-03-21End: 2023-06-13Updated: 2023-06-22

Phase 2

Study to Assess the Safety and Efficacy of SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)
CompletedNCT04540042
Tetherex Pharmaceuticals CorporationAsthma, Chronic Obstructive Pulmonary Disease
Start: 2020-08-18End: 2022-01-13Updated: 2022-02-02

Phase 3

Efficacy and Safety Trial of Verubecestat (MK-8931) in Participants With Prodromal Alzheimer's Disease (MK-8931-019)
TerminatedNCT01953601
Merck Sharp & Dohme LLCAlzheimer's Disease, Amnestic Mild Cognitive Impairment, Prodromal Alzheimer's Disease
Start: 2013-11-05End: 2018-04-17Updated: 2019-05-17

Related Papers

Pooled Modeling of Disease Progression in Two BACE1 Inhibitor Verubecestat Trials in Prodromal to Moderate Alzheimer’s Disease
Alzheimer s & Dementia2023-12-01
A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials.
2022-04-063 citations
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat.
2022-04-062 citations
P1‐044: VERUBECESTAT DISEASE PROGRESSION MODELING FROM APECS, A PHASE 3 TRIAL IN PRODROMAL ALZHEIMER'S DISEASE: NO DOSE‐ AND EXPOSURE‐DEPENDENCY IN CLINICAL ENDPOINTS
Alzheimer s & Dementia2019-07-01
P3‐040: VERUBECESTAT PHARMACOKINETIC AND EXPOSURE‐RESPONSE RESULTS FROM APECS, A PHASE 3 TRIAL IN PRODROMAL ALZHEIMER'S DISEASE
Alzheimer s & Dementia2019-07-01
Randomized Trial of Verubecestat for Prodromal Alzheimer’s Disease
New England Journal of Medicine2019-04-10535 citations
Pharmacodynamics of atabecestat (JNJ-54861911), an oral BACE1 inhibitor in patients with early Alzheimer’s disease: randomized, double-blind, placebo-controlled study
Alzheimer s Research & Therapy2018-08-22106 citations
P4‐013: DESIGN OF A PHASE‐3 TRIAL (APECS) TO EVALUATE THE BACE INHIBITOR VERUBECESTAT IN PRODROMAL AD
Alzheimer s & Dementia2018-07-01
POTENTIAL THERAPEUTIC BENEFITS OF DECREASING Aβ PRODUCTION THROUGH BACE INHIBITION
Innovation in Aging2017-06-30