HealthyPhase 1NCT06647628
A Clinical Study of MK-1708 in Healthy Elderly Participants (MK-1708-005)
A Phase 1 study testing MK-1708 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The purpose of this study is to learn about the safety of MK-1708, and how well elderly people tolerate it. The study will also measure what happens to MK-1708 in a healthy elderly person's body over time (pharmacokinetic or PK study). Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-1708
- 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
- 4 Nov 2024to 31 Mar 2025
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy). Participants with definitively treated disease who, in the opinion of the study investigator, are highly unlikely to have a recurrence for the duration of the study may be enrolled at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale, Florida, 33009
About this study
Official title: A Randomized, Double Blind Clinical Trial to Assess Safety, Tolerability and Pharmacokinetics of MK-1708 in Healthy Elderly Participants
The purpose of this study is to learn about the safety of MK-1708, and how well elderly people tolerate it. The study will also measure what happens to MK-1708 in a healthy elderly person's body over time (pharmacokinetic or PK study). Researchers will learn if at least 1 dose level of MK-1708 will be safe, well-tolerated, and will be above a certain level in people's blood after 24 hours.
- Conditions
- Healthy
- Being tested
- MK-1708, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1708Drug
MK-1708 oral suspension
PlaceboDrug
Placebo oral suspension
| Study group | Role | What they receive |
|---|---|---|
| MK-1708 Dosage 1 | Experimental | Participants receive multiple doses of MK-1708 dosage 1. Receives: Drug: MK-1708 |
| MK-1708 Dosage 2 | Experimental | Participants receive multiple doses of MK-1708 dosage 2. Receives: Drug: MK-1708 |
| Placebo | Placebo comparator | Participants receive multiple doses of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ≥1 adverse event (AE)
Measured: Up to 14 days after the last dose
Number of participants discontinuing study therapy due to AE
Measured: Up to ~2 weeks
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of multiple MK-1708 doses
Measured: At designated time points up to ~2 weeks
Maximum plasma concentration (Cmax) of multiple MK-1708 doses
Measured: At designated time points up to ~20 days
Time to maximum plasma concentration (Tmax) of multiple MK-1708 doses
Measured: At designated time points up to ~20 days
Concentration 24 hours postdose (C24) of multiple MK-1708 doses
Measured: At designated time points up to ~2 weeks
Apparent oral clearance (CL/F) of multiple MK-1708 doses, at steady state
Measured: At designated time points up to ~20 days
Apparent volume of distribution (Vz/F) of multiple MK-1708 doses, at steady state
Measured: At designated time points up to ~20 days
Apparent terminal half-life (t½) of multiple MK-1708 doses
Measured: At designated time points up to ~20 days
AUC0-24 accumulation ratio of multiple MK-1708 doses
Measured: At designated time points up to ~2 weeks
Cmax accumulation ratio of multiple MK-1708 doses
Measured: At designated time points up to ~20 days
C24 accumulation ratio of multiple MK-1708 doses
Measured: At designated time points up to ~2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start4 Nov 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
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
- Model description
- 8 participants will be randomized to receive either placebo or MK-1708 dose level 1, then 8 participants will be randomized to receive either placebo or MK-1708 dose level 2.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647628
- Sponsor's protocol ID
- 1708-005
- Status last verified
- May 2025
- First submitted
- 15 Oct 2024
- Last updated
- 15 May 2025
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Clinical Trial to Assess Safety, Tolerability and Pharmacokinetics of MK-1708 in Healthy Elderly Participants
- ClinicalTrials.gov ID
- NCT06647628
- Acronym / sponsor ID
- 1708-005
- 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
- 4 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 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 purpose of this study is to learn about the safety of MK-1708, and how well elderly people tolerate it. The study will also measure what happens to MK-1708 in a healthy elderly person's body over time (pharmacokinetic or PK study). Researchers will learn if at least 1 dose level of MK-1708 will be safe, well-tolerated, and will be above a certain level in people's blood after 24 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 8 participants will be randomized to receive either placebo or MK-1708 dose level 1, then 8 participants will be randomized to receive either placebo or MK-1708 dose level 2.
| Arm | Type | Receives |
|---|---|---|
| MK-1708 Dosage 1 | Experimental | Drug: MK-1708Participants receive multiple doses of MK-1708 dosage 1. |
| MK-1708 Dosage 2 | Experimental | Drug: MK-1708Participants receive multiple doses of MK-1708 dosage 2. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive multiple doses of placebo. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Is in good health before randomization
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy). Participants with definitively treated disease who, in the opinion of the study investigator, are highly unlikely to have a recurrence for the duration of the study may be enrolled at the discretion of the investigator
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-1708MK-1708 oral suspension | Drug | MK-1708 Dosage 1, MK-1708 Dosage 2 |
| PlaceboPlacebo oral suspension | Drug | Placebo |
Primary outcome
Number of participants with ≥1 adverse event (AE)
Time frame: Up to 14 days after the last dose
Number of participants discontinuing study therapy due to AE
Time frame: Up to ~2 weeks
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of multiple MK-1708 doses
Time frame: At designated time points up to ~2 weeks
Maximum plasma concentration (Cmax) of multiple MK-1708 doses
Time frame: At designated time points up to ~20 days
Time to maximum plasma concentration (Tmax) of multiple MK-1708 doses
Time frame: At designated time points up to ~20 days
Concentration 24 hours postdose (C24) of multiple MK-1708 doses
Time frame: At designated time points up to ~2 weeks
Apparent oral clearance (CL/F) of multiple MK-1708 doses, at steady state
Time frame: At designated time points up to ~20 days
Apparent volume of distribution (Vz/F) of multiple MK-1708 doses, at steady state
Time frame: At designated time points up to ~20 days
Apparent terminal half-life (t½) of multiple MK-1708 doses
Time frame: At designated time points up to ~20 days
AUC0-24 accumulation ratio of multiple MK-1708 doses
Time frame: At designated time points up to ~2 weeks
Cmax accumulation ratio of multiple MK-1708 doses
Time frame: At designated time points up to ~20 days
C24 accumulation ratio of multiple MK-1708 doses
Time frame: At designated time points up to ~2 weeks
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 May 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/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.
Study 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-1708 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 3 inclusion and 3 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 May 2025. 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. Some participants in this study may receive a placebo. 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 with ≥1 adverse event (AE) (time frame: Up to 14 days after the last dose). The study lists 12 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 May 2025.