HealthyPhase 1NCT07305831
A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012)
A Phase 1 study testing Ulonivirine 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 treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. 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?
- Ulonivirine and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2026to 9 Apr 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 before randomization
- Has body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
Who cannot join
- 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 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
ICON Early Phase Services (0001)
San Antonio, Texas, 78209
About this study
Official title: A Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of MK-8507 on the QTc Interval in Healthy Adult Participants
Researchers are looking for new treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.
Ulonivirine (MK-8507) is a study medicine designed to treat HIV-1
The goal of this study is to learn if ulonivirine does not increase the QT interval (a measure of heart rhythm on an electrocardiogram) above a certain amount. Researchers also want to learn what happens to the amount of ulonivirine in a healthy person's body over time.
- Conditions
- Healthy
- Being tested
- Ulonivirine, Moxifloxacin, Ulonivirine Placebo, Moxifloxacin Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlonivirineDrug
Also called MK-8507, ULO
Oral tablet
MoxifloxacinDrug
Oral tablet
Ulonivirine PlaceboDrug
Oral tablet
Moxifloxacin PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin 400 mg + Placebo (Arm 1) | Experimental | Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg. Receives: Drug: Moxifloxacin; Drug: Ulonivirine Placebo; Drug: Moxifloxacin Placebo |
| Ulonivirine Dose 1 + Placebo (Arm 2) | Experimental | Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1. Receives: Drug: Ulonivirine; Drug: Ulonivirine Placebo; Drug: Moxifloxacin 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 Ulonivirine Administration
Change from baseline in QTc following ulonivirine administration will be reported.
Measured: Baseline and up to approximately 24 hours
Plasma Concentration of Ulonivirine at QTc Intervals (Cqtc)
Blood samples will be collected to determine the Cqtc of ulonivirine.
Measured: At designated timepoints (up to approximately 24 hours)
Secondary outcomes (6)
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Administration
Change from baseline in QTc following moxifloxacin administration will be reported.
Measured: Baseline to up to approximately 24 hours
Plasma concentration of Moxifloxacin at QTc intervals (Cqtc)
Blood samples will be collected to determine the Cqtc of moxifloxacin.
Measured: At designated timepoints (up to approximately 24 hours)
Maximum Plasma Concentration (Cmax) of Moxifloxacin
Blood samples will be collected to determine the Cmax of moxifloxacin.
Measured: At designated timepoints (up to approximately 168 hours)
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ulonivirine
Blood samples will be collected to determine the AUC0-24 of ulonivirine.
Measured: At designated timepoints (up to 168 hours)
Maximum Plasma Concentration (Cmax) of Ulonivirine
Blood samples will be collected to determine the Cmax of ulonivirine.
Measured: At designated timepoints (up to 168 hours)
Time to Maximum Plasma Concentration (Tmax) of Ulonivirine
Blood samples will be collected to determine the Tmax of ulonivirine.
Measured: At designated timepoints (up to 168 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start22 Jan 2026
- Primary completion9 Apr 2026
- Study completion9 Apr 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT07305831
- Sponsor's protocol ID
- 8507-012
- Other IDs
- MK-8507-012
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2025
- Last updated
- 21 Apr 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of MK-8507 on the QTc Interval in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07305831
- Acronym / sponsor ID
- 8507-012
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 26 Dec 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 treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.
Ulonivirine (MK-8507) is a study medicine designed to treat HIV-1
The goal of this study is to learn if ulonivirine does not increase the QT interval (a measure of heart rhythm on an electrocardiogram) above a certain amount. Researchers also want to learn what happens to the amount of ulonivirine in a healthy person's body over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin 400 mg + Placebo (Arm 1) | Experimental | Drug: Moxifloxacin, Drug: Ulonivirine Placebo, Drug: Moxifloxacin PlaceboParticipants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg. |
| Ulonivirine Dose 1 + Placebo (Arm 2) | Experimental | Drug: Ulonivirine, Drug: Ulonivirine Placebo, Drug: Moxifloxacin PlaceboParticipants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1. |
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 before randomization
- Has body Mass Index (BMI) between 18 and 32 kg/m2, 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 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 |
|---|---|---|
| UlonivirineAlso: MK-8507, ULOOral tablet | Drug | Ulonivirine Dose 1 + Placebo (Arm 2) |
| MoxifloxacinOral tablet | Drug | Moxifloxacin 400 mg + Placebo (Arm 1) |
| Ulonivirine PlaceboOral tablet | Drug | Moxifloxacin 400 mg + Placebo (Arm 1), Ulonivirine Dose 1 + Placebo (Arm 2) |
| Moxifloxacin PlaceboOral tablet | Drug | Moxifloxacin 400 mg + Placebo (Arm 1), Ulonivirine Dose 1 + Placebo (Arm 2) |
Primary outcome
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Ulonivirine Administration
Time frame: Baseline and up to approximately 24 hours
Change from baseline in QTc following ulonivirine administration will be reported.
Plasma Concentration of Ulonivirine at QTc Intervals (Cqtc)
Time frame: At designated timepoints (up to approximately 24 hours)
Blood samples will be collected to determine the Cqtc of ulonivirine.
6 secondary outcomes
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Administration
Time frame: Baseline to up to approximately 24 hours
Plasma concentration of Moxifloxacin at QTc intervals (Cqtc)
Time frame: At designated timepoints (up to approximately 24 hours)
Maximum Plasma Concentration (Cmax) of Moxifloxacin
Time frame: At designated timepoints (up to approximately 168 hours)
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ulonivirine
Time frame: At designated timepoints (up to 168 hours)
Maximum Plasma Concentration (Cmax) of Ulonivirine
Time frame: At designated timepoints (up to 168 hours)
Time to Maximum Plasma Concentration (Tmax) of Ulonivirine
Time frame: At designated timepoints (up to 168 hours)
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 21 Apr 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 Ulonivirine 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 2 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 21 Apr 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 Ulonivirine Administration (time frame: Baseline and up to approximately 24 hours). The study lists 2 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 21 Apr 2026.