Alzheimer's Disease, Treatment-Resistant Depression
Conditions
Interventions
Single dose administration of MK-1942 (4, 8 or 10 mg) in the fasted state, single dose administration of MK-1942 (4 mg) in the fed state or multiple dose administration for 28 days of MK-1942 (8, 15,
Sponsors
Tanaka Yoshiyuki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy male aged 20 to 45 years old with BMI 18.5 to 25.0 kg/m2
Exclusion criteria
Exclusion criteria: Has a history of clinically significant abnormalities or diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 (Single dose): -Adverse events, vital signs, laboratory safety tests, 12-lead electrocardiograms, physical examinations, neurological exams Part 2 (Multiple dose): -Adverse events, vital signs, laboratory safety tests, 12-lead electrocardiograms, physical examinations, neurological exams, Columbia suicide severity rating scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 (Single dose): -AUC0-inf, Cmax, Tmax, apparent terminal t1/2, CL/F and Vz/F in the fasted state -AUC0-inf and Cmax in the fasted and fed state -AUC0-inf and Cmax in the fasted state between healthy Japanese participants with a CYP2C19 extensive metabolizer and poor metabolizer phenotype. Part 2 (Multiple dose): -Day 1: AUC0-12, Cmax, Tmax, Ctrough -Days 7, 14, 21 and 28: AUC0-12, Cmax, Tmax, Ctrough, apparent terminal t1/2*, CL/F, Vz/F, accumulation ratios** * Following last dose only ** Day 7 only | — |
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed