HealthyPhase 1NCT07334860
A Clinical Trial to Compare Forms of MK-1167 in Healthy People (MK-1167-011)
A Phase 1 study testing MK-1167 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-1167
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2026to 20 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health
- Has a body mass index (BMI) ≥18 and ≤ 32 kg/m^2, inclusive
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
QPS-MRA, LLC ( Site 0001)
South Miami, Florida, 33143
About this study
Official title: A Two-Period, Open-label, Fixed-Sequence Study to Evaluate the Single-Dose Pharmacokinetics of Two Formulations of MK-1167 in Healthy Participants
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
- Being tested
- MK-1167
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1167Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: MK-1167 Form 2 | Experimental | Participants receive MK-1167 Form 2 orally. Receives: Drug: MK-1167 |
| Arm 2: MK-1167 Form 1 | Experimental | Participants receive MK-1167 Form 1 orally. Receives: Drug: MK-1167 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Blood samples will be collected to determine the AUC0-24 of MK-1167.
Measured: At designated time points (up to approximately 24 hours)
Concentration at 24 hours (C24) of MK-1167
Blood samples will be collected to determine the C24 of MK-1167.
Measured: At designated time points (up to approximately 24 hours)
Time to Maximum Serum Concentration (Tmax) of MK-1167
Blood samples will be collected to determine the Tmax of MK-1167.
Measured: At designated time points (up to approximately 21 days)
Apparent Terminal Half-life (t1/2) of MK-1167
Blood samples will be collected to determine the t1/2 of MK-1167.
Measured: At designated time points (up to approximately 21 days)
Apparent Clearance after Nonintravenous Administration (CL/F) of MK-1167
Blood samples will be collected to determine the CL/F of MK-1167.
Measured: At designated time points (up to approximately 21 days)
Apparent Volume of Distribution during Terminal Phase (Vz/F) of MK-1167
Blood samples will be collected to determine the Vz/F of MK-1167.
Measured: At designated time points (up to approximately 21 days)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 78 days
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start6 Feb 2026
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334860
- Sponsor's protocol ID
- 1167-011
- Other IDs
- MK-1167-011
- Status last verified
- Jun 2026
- First submitted
- 31 Dec 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Period, Open-label, Fixed-Sequence Study to Evaluate the Single-Dose Pharmacokinetics of Two Formulations of MK-1167 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07334860
- Acronym / sponsor ID
- 1167-011
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MK-1167 Form 2 | Experimental | Drug: MK-1167Participants receive MK-1167 Form 2 orally. |
| Arm 2: MK-1167 Form 1 | Experimental | Drug: MK-1167Participants receive MK-1167 Form 1 orally. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health
- Has a body mass index (BMI) ≥18 and ≤ 32 kg/m^2, inclusive
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-1167Oral administration | Drug | Arm 1: MK-1167 Form 2, Arm 2: MK-1167 Form 1 |
Primary outcome
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1167
Time frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the AUC0-inf of MK-1167.
Maximum Plasma Concentration (Cmax) of MK-1167
Time frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the Cmax of MK-1167.
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) of MK-1167
Time frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the AUC0-last of MK-1167.
8 secondary outcomes
Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-1167
Time frame: At designated time points (up to approximately 24 hours)
Concentration at 24 hours (C24) of MK-1167
Time frame: At designated time points (up to approximately 24 hours)
Time to Maximum Serum Concentration (Tmax) of MK-1167
Time frame: At designated time points (up to approximately 21 days)
Apparent Terminal Half-life (t1/2) of MK-1167
Time frame: At designated time points (up to approximately 21 days)
Apparent Clearance after Nonintravenous Administration (CL/F) of MK-1167
Time frame: At designated time points (up to approximately 21 days)
Apparent Volume of Distribution during Terminal Phase (Vz/F) of MK-1167
Time frame: At designated time points (up to approximately 21 days)
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 78 days
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-1167 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1167 (time frame: At designated time points (up to approximately 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.