A Clinical Trial to Compare Forms of MK-1167 in Healthy People (MK-1167-011)

NCT07334860 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1167-011MK-1167-011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are looking for new ways to treat Alzheimer's disease (AD). AD is a brain disease that causes a gradual decline in memory, thinking, and ability to carry out daily tasks. MK-1167 is a study medicine designed to treat symptoms of AD. Before giving a study medicine to people with a health condition, researchers first do studies in healthy people to find a safe dose of the study medicine. The goals of the trial are to learn:

• What happens to different forms of MK-1167 in a healthy person's body over time
• About the safety of MK-1167 and if people tolerate it

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1167

  Blood samples will be collected to determine the AUC0-inf of MK-1167.

  At designated time points (up to approximately 21 days)

• Maximum Plasma Concentration (Cmax) of MK-1167

  Blood samples will be collected to determine the Cmax of MK-1167.

  At designated time points (up to approximately 21 days)

• Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) of MK-1167

  Blood samples will be collected to determine the AUC0-last of MK-1167.

  At designated time points (up to approximately 21 days)

Secondary Outcomes (8)

• Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-1167

  At designated time points (up to approximately 24 hours)

• Concentration at 24 hours (C24) of MK-1167

  At designated time points (up to approximately 24 hours)

• Time to Maximum Serum Concentration (Tmax) of MK-1167

  At designated time points (up to approximately 21 days)

• Apparent Terminal Half-life (t1/2) of MK-1167

  At designated time points (up to approximately 21 days)

• Apparent Clearance after Nonintravenous Administration (CL/F) of MK-1167

  At designated time points (up to approximately 21 days)

Study Arms (2)

Arm 1: MK-1167 Form 2

EXPERIMENTAL

Participants receive MK-1167 Form 2 orally.

Drug: MK-1167

Arm 2: MK-1167 Form 1

EXPERIMENTAL

Participants receive MK-1167 Form 1 orally.

Drug: MK-1167

Interventions

MK-1167 DRUG

Oral administration

Arm 1: MK-1167 Form 2; Arm 2: MK-1167 Form 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health
• Has a body mass index (BMI) ≥18 and ≤ 32 kg/m\^2, inclusive

You may not qualify if:

• Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
• Is a smoker and/or has used nicotine or nicotine-containing products within the past 3 months.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

QPS-MRA, LLC ( Site 0001)

South Miami, Florida, 33143, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: February 6, 2026
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)