Healthy
Conditions
Brief summary
The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it.
Interventions
DRUGMK-1167
Oral Administration
DRUGPlacebo
Oral Administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Be in good health The main
Exclusion criteria
include but are not limited to the following: * History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. * History of cancer (malignancy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | Up to approximately 41 days | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. |
| Number of Participants Discontinuing Study Treatment due to an AE | Up to approximately 16 days | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. |
| Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1167 after Multiple Doses | Predose and at designated timepoints up to 24 hours postdose on days 1, 8 and 16 | Blood samples will be collected to determine the AUC0-24 of MK-1167. |
| Maximum Concentration (Cmax) of MK-1167 after Multiple Doses | Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16 | Blood samples will be collected to determine the Cmax of MK-1167. |
| Concentration at 24 hours (C24) of MK-1167 after Multiple Doses | 24 hours postdose on days 1, 8 and 16 | Blood samples will be collected to determine the C24 of MK-1167. |
| Time to reach maximum concentration (Tmax) of MK-1167 after Multiple Doses | Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16 | Blood samples will be collected to determine the Tmax of MK-1167. |
| Apparent Clearance (CL/F) of MK-1167 after Multiple Doses | Predose and at designated timepoints up to 600 hours postdose on day 16 | Blood samples will be collected to determine the CL/F of MK-1167. |
| Volume of Distribution (Vz/F) of MK-1167 at Steady State after Multiple Doses | Predose and at designated timepoints up to 600 hours postdose on day 16 | Blood samples will be collected to determine the Vz/F of MK-1167. |
| Apparent Half Life (t½) of MK-1167 after Multiple Doses | Predose and at designated timepoints up to 600 hours postdose on day 16 | Blood samples will be collected to determine the t½ of MK-1167. |
Countries
United States
Outcome results
None listed