HealthyPhase 1NCT07063238
A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)
A Phase 1 study testing MK-8527 and Moxifloxacin in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). 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-8527 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 29 Dec 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
- Has history of cancer (malignancy).
- Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hassman Research Institute Marlton Site ( Site 0001)
Marlton, New Jersey, 08053
About this study
Official title: A Double-Blind, Placebo-Controlled and Active-controlled Trial to Evaluate the Effect of a Supratherapeutic Dose of MK-8527 on the QTc Interval in Healthy Adult Participants
Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often.
MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet.
The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
- Conditions
- Healthy
- Being tested
- MK-8527, Moxifloxacin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8527Drug
Oral administration
MoxifloxacinDrug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| MK-8527 PLUS Moxifloxacin and Placebo | Experimental | Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization. Receives: Drug: MK-8527; Drug: Moxifloxacin; Drug: Placebo |
| Moxifloxacin PLUS MK-8527 and Placebo | Experimental | Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization. Receives: Drug: MK-8527; Drug: Moxifloxacin; Drug: Placebo |
| Placebo PLUS MK-8527 and Moxifloxacin | Experimental | Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization. Receives: Drug: MK-8527; Drug: Moxifloxacin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration
Change from Baseline in QTc following MK-8527 administration will be reported.
Measured: Baseline and up to approximately 24 hours
Secondary outcomes (8)
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.
Measured: Up to approximately 7 weeks
Number of participants who discontinue study intervention due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.
Measured: Up to approximately 7 weeks
Change from Baseline in QTc following moxifloxacin administration
Change from Baseline in QTc following moxifloxacin administration will be reported.
Measured: Baseline and up to approximately 24 hours
Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8527
Blood samples will be collected at multiple time points to estimate AUC0-24 of MK-8527
Measured: At designated timepoints (up to 24 hours postdose)
Area Under the Plasma Concentration-Time curve From Time 0 to 168 hours (AUC0-168) of MK-8527
Blood samples will be collected at multiple time points to estimate AUC0-168 of MK-8527
Measured: At designated timepoints (up to 168 hours postdose)
Area Under the Plasma Concentration-Time curve From Time 0 to infinity (AUC0-inf) of MK-8527
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527
Measured: At designated timepoints (up to approximately 7 weeks)
Maximum plasma concentration (Cmax) of MK-8527
Blood samples will be collected at multiple time points to estimate Cmax of MK-8527
Measured: At designated timepoints (up to approximately 7 weeks)
Time to maximum plasma concentration (Tmax) of MK-8527
Blood samples will be collected at multiple time points to estimate Tmax of MK-8527
Measured: At designated timepoints (up to approximately 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start12 Aug 2025
- Primary completion6 Dec 2025
- Study completion29 Dec 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 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
- NCT07063238
- Sponsor's protocol ID
- 8527-014
- Other IDs
- MK-8527-014
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2025
- Last updated
- 29 Jan 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled and Active-controlled Trial to Evaluate the Effect of a Supratherapeutic Dose of MK-8527 on the QTc Interval in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07063238
- Acronym / sponsor ID
- 8527-014
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 6 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 14 Jul 2025 (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 medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often.
MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet.
The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MK-8527 PLUS Moxifloxacin and Placebo | Experimental | Drug: MK-8527, Drug: Moxifloxacin, Drug: PlaceboParticipants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization. |
| Moxifloxacin PLUS MK-8527 and Placebo | Experimental | Drug: MK-8527, Drug: Moxifloxacin, Drug: PlaceboParticipants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization. |
| Placebo PLUS MK-8527 and Moxifloxacin | Experimental | Drug: MK-8527, Drug: Moxifloxacin, Drug: PlaceboParticipants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health before randomization
- Has body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Key exclusion criteria (4 listed)
- Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
- Has history of cancer (malignancy).
- Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
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-8527Oral administration | Drug | MK-8527 PLUS Moxifloxacin and Placebo, Moxifloxacin PLUS MK-8527 and Placebo, Placebo PLUS MK-8527 and Moxifloxacin |
| MoxifloxacinOral administration | Drug | MK-8527 PLUS Moxifloxacin and Placebo, Moxifloxacin PLUS MK-8527 and Placebo, Placebo PLUS MK-8527 and Moxifloxacin |
| PlaceboOral administration | Drug | MK-8527 PLUS Moxifloxacin and Placebo, Moxifloxacin PLUS MK-8527 and Placebo, Placebo PLUS MK-8527 and Moxifloxacin |
Primary outcome
Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration
Time frame: Baseline and up to approximately 24 hours
Change from Baseline in QTc following MK-8527 administration will be reported.
8 secondary outcomes
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to approximately 7 weeks
Number of participants who discontinue study intervention due to an AE
Time frame: Up to approximately 7 weeks
Change from Baseline in QTc following moxifloxacin administration
Time frame: Baseline and up to approximately 24 hours
Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8527
Time frame: At designated timepoints (up to 24 hours postdose)
Area Under the Plasma Concentration-Time curve From Time 0 to 168 hours (AUC0-168) of MK-8527
Time frame: At designated timepoints (up to 168 hours postdose)
Area Under the Plasma Concentration-Time curve From Time 0 to infinity (AUC0-inf) of MK-8527
Time frame: At designated timepoints (up to approximately 7 weeks)
Maximum plasma concentration (Cmax) of MK-8527
Time frame: At designated timepoints (up to approximately 7 weeks)
Time to maximum plasma concentration (Tmax) of MK-8527
Time frame: At designated timepoints (up to approximately 7 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 29 Jan 2026.
- 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.
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-8527 and Moxifloxacin 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 4 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 29 Jan 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?
Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration (time frame: Baseline and up to approximately 24 hours). 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 29 Jan 2026.