HealthyPhase 1NCT07530289
A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018)
A Phase 1 study testing Atorvastatin, Metformin and Ulonivirine in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
Researchers want to learn about ulonivirine when given with atorvastatin and metformin in healthy people. The goal of this study is to compare the amount of atorvastatin and metformin in a person's body over time when given with and without ulonivirine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atorvastatin, Metformin and Ulonivirine
- 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
- 29 Apr 2026to 3 Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has body mass index (BMI) 18.0 and ≤ 32.0 kg/m^2
- Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiogram (ECG)
Who cannot join
- Has history of cancer (malignancy)
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Two-Period Fixed Sequence Study to Evaluate the Effects of a Single Oral Dose of Ulonivirine (MK-8507) on the Single-Dose Pharmacokinetics of Atorvastatin and Metformin in Healthy Adult Participants
Researchers want to learn about ulonivirine when given with atorvastatin and metformin in healthy people. The goal of this study is to compare the amount of atorvastatin and metformin in a person's body over time when given with and without ulonivirine.
- Conditions
- Healthy
- Being tested
- Atorvastatin, Metformin, Ulonivirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Oral tablet
MetforminDrug
Oral tablet
UlonivirineDrug
Also called MK-8507
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin + metformin + ulonivirine | Experimental | In Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine. Receives: Drug: Atorvastatin; Drug: Metformin; Drug: Ulonivirine |
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 Atorvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of Metformin
Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Secondary outcomes (24)
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Atorvastatin
Blood samples will be collected at multiple time points to determine the AUC0-last of atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Maximum Plasma Concentration (Cmax) of Atorvastatin
Blood samples will be collected at multiple time points to determine the Cmax of atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Plasma Concentration at 24 Hours (C24) of Atorvastatin
Blood samples will be collected to estimate the C24 of atorvastatin
Measured: 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin
Blood samples will be collected at multiple time points to estimate the Tmax of atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Apparent Terminal Half-life (t1/2) of Atorvastatin
Blood samples will be collected at multiple time points to estimate the t1/2 of atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Atorvastatin Metabolite (2-OH Atorvastatin)
Blood samples will be collected at multiple time points to determine the AUC0-last of 2-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of 2-OH Atorvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of 2-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of 2-OH Atorvastatin
Blood samples will be collected at multiple time points to determine the Cmax of 2-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of 2-OH Atorvastatin
Blood samples will be collected to estimate the C24 of 2-OH atorvastatin
Measured: 24 hours post-dose
Tmax of 2-OH Atorvastatin
Blood samples will be collected at multiple time points to estimate the Tmax of 2-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of 2-OH Atorvastatin
Blood samples will be collected at multiple time points to estimate the t1/2 of 2-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Atorvastatin Metabolite (4-OH Atorvastatin)
Blood samples will be collected at multiple time points to determine the AUC0-last of 4-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of 4-OH Atorvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of 4-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of 4-OH Atorvastatin
Blood samples will be collected at multiple time points to determine the Cmax of 4-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of 4-OH Atorvastatin
Blood samples will be collected to estimate the C24 of 4-OH atorvastatin
Measured: 24 hours post-dose
Tmax of 4-OH Atorvastatin
Blood samples will be collected at multiple time points to estimate the Tmax of 4-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of 4-OH Atorvastatin
Blood samples will be collected at multiple time points to estimate the t1/2 of 4-OH atorvastatin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Metformin
Blood samples will be collected at multiple time points to determine the AUC0-last of metformin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of Metformin
Blood samples will be collected at multiple time points to determine the Cmax of metformin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of Metformin
Blood samples will be collected to estimate the C24 of metformin
Measured: 24 hours post-dose
Tmax of Metformin
Blood samples will be collected at multiple time points to estimate the Tmax of metformin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Metformin
Blood samples will be collected at multiple time points to estimate the t1/2 of metformin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The number of participants who experience an AE will be reported.
Measured: Up to approximately 21 days after first dose
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 7 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start29 Apr 2026
- Primary completion23 May 2026
- Study completion3 Jun 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- NCT07530289
- Sponsor's protocol ID
- 8507-018
- Other IDs
- MK-8507-018
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 15 Jun 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Two-Period Fixed Sequence Study to Evaluate the Effects of a Single Oral Dose of Ulonivirine (MK-8507) on the Single-Dose Pharmacokinetics of Atorvastatin and Metformin in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07530289
- Acronym / sponsor ID
- 8507-018
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 23 May 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 15 Apr 2026 (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 want to learn about ulonivirine when given with atorvastatin and metformin in healthy people. The goal of this study is to compare the amount of atorvastatin and metformin in a person's body over time when given with and without ulonivirine.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin + metformin + ulonivirine | Experimental | Drug: Atorvastatin, Drug: Metformin, Drug: UlonivirineIn Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has body mass index (BMI) 18.0 and ≤ 32.0 kg/m^2
- Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiogram (ECG)
Key exclusion criteria (2 listed)
- Has history of cancer (malignancy)
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
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 |
|---|---|---|
| AtorvastatinOral tablet | Drug | Atorvastatin + metformin + ulonivirine |
| MetforminOral tablet | Drug | Atorvastatin + metformin + ulonivirine |
| UlonivirineAlso: MK-8507Oral tablet | Drug | Atorvastatin + metformin + ulonivirine |
Primary outcome
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Blood samples will be collected at multiple time points to determine the AUC0-inf of atorvastatin
AUC0-inf of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin
24 secondary outcomes
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Maximum Plasma Concentration (Cmax) of Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Plasma Concentration at 24 Hours (C24) of Atorvastatin
Time frame: 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Apparent Terminal Half-life (t1/2) of Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Atorvastatin Metabolite (2-OH Atorvastatin)
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of 2-OH Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of 2-OH Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of 2-OH Atorvastatin
Time frame: 24 hours post-dose
Tmax of 2-OH Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of 2-OH Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Atorvastatin Metabolite (4-OH Atorvastatin)
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of 4-OH Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of 4-OH Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of 4-OH Atorvastatin
Time frame: 24 hours post-dose
Tmax of 4-OH Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of 4-OH Atorvastatin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of Metformin
Time frame: 24 hours post-dose
Tmax of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 21 days after first dose
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 7 days after first dose
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 Jun 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 Atorvastatin, Metformin and Ulonivirine 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 2 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 Jun 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?
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Atorvastatin (time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose). 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 15 Jun 2026.