Single and Multiple Dose Study of MK-1708 in Healthy Japanese Participants (MK-1708-004)

A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1708 in Healthy Japanese Participants

This is a study of the safety, tolerability, and pharmacokinetics (PK) of MK-1708 in healthy Japanese participants. The primary objectives are to evaluate the safety and tolerability of single (Part 1) and multiple (Part 2) doses of MK-1708.

Study Overview

• Status: Not yet recruiting
• Conditions: Amyotrophic Lateral Sclerosis; Alzheimer Disease
• Intervention / Treatment: Drug: Placebo; Drug: MK-1708

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Be in good health
• Body Mass Index (BMI) of18 to 32 kg/m^2

Exclusion Criteria:

• History of significant clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Mentally incapacitated
• History of cancer (malignancy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Panel A; Participants in Panel A receive single doses of placebo or MK-1708 Dose 1 (Period 1) and Dose 3 (Period 2).	Drug: Placebo; Placebo oral suspension; Drug: MK-1708; MK-1708 oral suspension
Experimental: Part 1: Panel B; Participants in Panel B receive single doses of placebo or MK-1708 Dose 2 (Period 1) and Dose 4 (Period 2).	Drug: Placebo; Placebo oral suspension; Drug: MK-1708; MK-1708 oral suspension
Experimental: Part 1: Panel C; Participants in Panel C receive a single dose of placebo or MK-1708 Dose 1 in Period 1.	Drug: Placebo; Placebo oral suspension; Drug: MK-1708; MK-1708 oral suspension
Experimental: Part 1: Panel D; Participants in Panel D receive single doses of placebo or MK-1708 Dose 1 (Period 1) and Dose 3 (Period 2).	Drug: Placebo; Placebo oral suspension; Drug: MK-1708; MK-1708 oral suspension
Experimental: Part 1: Panel E; Participants in Panel E receive single doses of placebo or MK-1708 Dose 2 (Period 1) and Dose 4 (Period 2).	Drug: Placebo; Placebo oral suspension; Drug: MK-1708; MK-1708 oral suspension
Experimental: Part 2: Panel F; Participants in Panel F receive multiple doses of placebo or MK-1708.	Drug: Placebo; Placebo oral suspension; Drug: MK-1708; MK-1708 oral suspension
Experimental: Part 2: Panel G; Participants in Panel G receive multiple doses of placebo or MK-1708.	Drug: Placebo; Placebo oral suspension; Drug: MK-1708; MK-1708 oral suspension
Experimental: Part 2: Panel H; Participants in Panel H receive multiple doses of placebo or MK-1708.	Drug: Placebo; Placebo oral suspension; Drug: MK-1708; MK-1708 oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Number of participants with ≥ adverse event (AE)	Up to 14 days postdose
Part 2: Number of participants with ≥ AE	Up to 14 days after the last dose
Part 1: Number of participants discontinuing study therapy due to AE	Up to 1 day
Part 2: Number of participants discontinuing study therapy due to AE	Up to 12 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single MK-1708 doses	At designated time points up to ~1 week
Area under the plasma concentration-time curve from dosing to last measurable concentration (AUC0-last) of single MK-1708 doses	At designated time points up to ~1 week
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single MK-1708 doses	At designated time points up to ~1 week
Maximum plasma concentration (Cmax) of single MK-1708 doses	At designated time points up to ~1 week
Concentration 24 hours postdose (C24) of single MK-1708 doses	At designated time points up to ~1 week
Time to maximum plasma concentration (Tmax) of single MK-1708 doses	At designated time points up to ~1 week
Apparent terminal half-life (t½) of single MK-1708 doses	At designated time points up to ~1 week
Apparent oral clearance (CL/F) of single MK-1708 doses	At designated time points up to ~1 week
Volume of distribution (Vz/F) of single MK-1708 doses	At designated time points up to ~1 week
AUC0-24 of multiple MK-1708 doses	At designated time points up to ~2 weeks after the last dose
Cmax of multiple MK-1708 doses	At designated time points up to ~2 weeks after the last dose
C24 of multiple MK-1708 doses	At designated time points up to ~2 weeks after the last dose
t½ of multiple MK-1708 doses	At designated time points up to ~2 weeks after the last dose
CL/F of multiple MK-1708 doses	At designated time points up to ~2 weeks after the last dose
Vz/F of multiple MK-1708 doses	At designated time points up to ~2 weeks after the last dose
AUC0-∞ of single MK-1708 doses in CYP2C19 extensive metabolizer (EM), intermediate metabolizer (IM), and poor metabolizer (PM) phenotypes	At designated time points up to ~1 week
Accumulation ratio of multiple MK-1708 doses	Day 12 and Day 1

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Chair: Study Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Estimated): August 22, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Estimated): August 22, 2024

Study Record Updates

• Last Update Posted (Estimated): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Tauopathies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Alzheimer Disease
• Other Study ID Numbers: 1708-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes