drugset / Trial / NCT04308304

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)

NCT04308304

Phase 1 Completed 27 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The study investigated the effects on safety and pharmacokinetics (PK) of MK-1942 and donepezil when co-administered to participants with Alzheimer's Disease with mild-to-moderate cognitive impairment stably treated with donepezil. The objectives of this study were to determine if the combination of MK-1942 with donepezil increases the incidence or severity of adverse events (AEs) previously reported for these agents alone, or results in unanticipated AEs in the patient population targeted for MK-1942 treatment. In addition, changes in the PK parameters of either MK-1942 or donepezil as a result of co-administration were assessed.

Timeline

Start
2021-02-16
Primary completion
2022-05-18
Completion
2022-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule 5 mg Oral
Subject Donepezil Small molecule 10 mg Oral
Subject MK-1942 Unknown 8 mg Oral
Subject MK-1942 Unknown 15 mg Oral
Subject MK-1942 Unknown 30 mg Oral
Subject MK-1942 Unknown 50 mg Oral

Indications