Alzheimer's DiseasePhase 1NCT06586606
A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)
A Phase 1 study testing MK-1708 and Itraconazole in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- MK-1708 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 10 Dec 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- 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) ≥18.5 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
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 Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single Dose PK of MK-1708 in Healthy Participants
The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.
- Conditions
- Alzheimer's Disease
- Being tested
- MK-1708, Itraconazole
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1708Drug
Oral administration
ItraconazoleDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Period 1: MK-1708 | Experimental | Participants will receive a single oral dose of MK-1708 on Day 1. Receives: Drug: MK-1708 |
| Period 2: MK-1708 and Itraconazole | Experimental | A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4. Receives: Drug: MK-1708; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708
Blood samples will be collected to determine the AUC0-inf of MK-1708.
Measured: Predose and at designated timepoints up to approximately 2 weeks postdose
Number of Participants Who Experience an Adverse Event (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 experience an AE will be reported.
Measured: Up to approximately 11 weeks
Number of Participants Who Discontinue Study 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 due to an AE will be reported.
Measured: Up to approximately 11 weeks
Secondary outcomes (7)
Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708
Blood samples will be collected to determine the AUC0-last of MK-1708.
Measured: Predose and at designated timepoints up to approximately 2 weeks postdose
Maximum Plasma Concentration (Cmax) of MK-1708
Blood samples will be collected to determine the Cmax of MK-1708.
Measured: Predose and at designated timepoints up to approximately 2 weeks postdose
Time to Maximum Plasma Concentration (Tmax) of MK-1708
Blood samples will be collected to determine the Tmax of MK-1708.
Measured: Predose and at designated timepoints up to approximately 2 weeks postdose
Plasma Concentration at 24 Hours (C24) of MK-1708
Blood samples will be collected to determine the C24 of MK-1708.
Measured: Predose and at designated timepoints up to 24 hours postdose
Apparent Clearance (CL/F) of MK-1708
Blood samples will be collected to determine the CL/F of MK-1708.
Measured: Predose and at designated timepoints up to approximately 2 weeks postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708
Blood samples will be collected to determine the Vz/F of MK-1708.
Measured: Predose and at designated timepoints up to approximately 2 weeks postdose
Apparent Terminal Half-life (t1/2) of MK-1708
Blood samples will be collected to determine the t1/2 of MK-1708.
Measured: Predose and at designated timepoints up to approximately 2 weeks postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Oct 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT06586606
- Sponsor's protocol ID
- 1708-003
- Other IDs
- MK-1708-003
- Status last verified
- Dec 2024
- First submitted
- 4 Sep 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Period Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single Dose PK of MK-1708 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06586606
- Acronym / sponsor ID
- 1708-003
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 19 Sep 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 the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: MK-1708 | Experimental | Drug: MK-1708Participants will receive a single oral dose of MK-1708 on Day 1. |
| Period 2: MK-1708 and Itraconazole | Experimental | Drug: MK-1708, Drug: ItraconazoleA washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health before randomization
- Has a body mass index (BMI) ≥18.5 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
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-1708Oral administration | Drug | Period 1: MK-1708, Period 2: MK-1708 and Itraconazole |
| ItraconazoleOral administration | Drug | Period 2: MK-1708 and Itraconazole |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Blood samples will be collected to determine the AUC0-inf of MK-1708.
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 11 weeks
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.
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 11 weeks
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 due to an AE will be reported.
7 secondary outcomes
Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Maximum Plasma Concentration (Cmax) of MK-1708
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Time to Maximum Plasma Concentration (Tmax) of MK-1708
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Plasma Concentration at 24 Hours (C24) of MK-1708
Time frame: Predose and at designated timepoints up to 24 hours postdose
Apparent Clearance (CL/F) of MK-1708
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Apparent Terminal Half-life (t1/2) of MK-1708
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
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 18 Dec 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-1708 and Itraconazole in people with Alzheimer's Disease, 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 18 Dec 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?
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708 (time frame: Predose and at designated timepoints up to approximately 2 weeks postdose). 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 18 Dec 2024.