HealthyPhase 1NCT06625840
A Study of MK-1167 in Healthy Elderly Participants (MK-1167-004)
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
The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it. Read more about this study
- Who is it for?
- Ages 60 to 85 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?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 8 May 2024
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International (Site 0001)
Glendale, California, 91206
About this study
Official title: A Randomized, Double-Blind Clinical Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MK-1167 in Healthy Elderly Participants
The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it.
- Conditions
- Healthy
- Being tested
- MK-1167, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1167Drug
Oral Administration
PlaceboDrug
Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| Panel A | Experimental | 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. Receives: Drug: MK-1167; Drug: Placebo |
| Panel B | Experimental | 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. Receives: Drug: MK-1167; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing an Adverse Event (AE)
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.
Measured: Up to approximately 41 days
Number of Participants Discontinuing Study Treatment due to an AE
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.
Measured: Up to approximately 16 days
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1167 after Multiple Doses
Blood samples will be collected to determine the AUC0-24 of MK-1167.
Measured: Predose and at designated timepoints up to 24 hours postdose on days 1, 8 and 16
Maximum Concentration (Cmax) of MK-1167 after Multiple Doses
Blood samples will be collected to determine the Cmax of MK-1167.
Measured: Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16
Concentration at 24 hours (C24) of MK-1167 after Multiple Doses
Blood samples will be collected to determine the C24 of MK-1167.
Measured: 24 hours postdose on days 1, 8 and 16
Time to reach maximum concentration (Tmax) of MK-1167 after Multiple Doses
Blood samples will be collected to determine the Tmax of MK-1167.
Measured: Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16
Apparent Clearance (CL/F) of MK-1167 after Multiple Doses
Blood samples will be collected to determine the CL/F of MK-1167.
Measured: Predose and at designated timepoints up to 600 hours postdose on day 16
Volume of Distribution (Vz/F) of MK-1167 at Steady State after Multiple Doses
Blood samples will be collected to determine the Vz/F of MK-1167.
Measured: Predose and at designated timepoints up to 600 hours postdose on day 16
Apparent Half Life (t½) of MK-1167 after Multiple Doses
Blood samples will be collected to determine the t½ of MK-1167.
Measured: Predose and at designated timepoints up to 600 hours postdose on day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start18 Sep 2023
- Primary completion8 May 2024
- Study completion8 May 2024
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
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
- NCT06625840
- Sponsor's protocol ID
- 1167-004
- Other IDs
- MK-1167-004
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Clinical Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MK-1167 in Healthy Elderly Participants
- ClinicalTrials.gov ID
- NCT06625840
- Acronym / sponsor ID
- 1167-004
- 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
- 18 Sep 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 3 Oct 2024 (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.
The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panel A | Experimental | Drug: MK-1167, Drug: PlaceboParticipants 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 | Experimental | Drug: MK-1167, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 | Panel A, Panel B |
| PlaceboOral Administration | Drug | Panel A, Panel B |
Primary outcome
Number of Participants Experiencing an Adverse Event (AE)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
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 3 Oct 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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?
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 3 Oct 2024. 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?
Number of Participants Experiencing an Adverse Event (AE) (time frame: Up to approximately 41 days). The study lists 9 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 3 Oct 2024.