A Study of MK-1167 in Healthy Elderly Participants (MK-1167-004)
- Registration Number
- NCT06625840
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Panel A MK-1167 Participants receive a loading dose of MK-1167 or Placebo orally on day 1, followed by a once daily (QD) maintenance dose orally on days 2 to 16. Panel A Placebo Participants receive a loading dose of MK-1167 or Placebo orally on day 1, followed by a once daily (QD) maintenance dose orally on days 2 to 16. Panel B MK-1167 Participants receive a loading dose of MK-1167 or Placebo orally on days 1 to 3, followed by a QD maintenance dose orally on days 4 to 16. Panel B Placebo Participants receive a loading dose of MK-1167 or Placebo orally on days 1 to 3, followed by a QD maintenance dose orally on days 4 to 16.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International (Site 0001)
🇺🇸Glendale, California, United States