HealthyPhase 1NCT06811246
A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058)
A Phase 1 study testing Islatravir (ISL) and Lamivudine (3TC) in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn what happens to the medication islatravir (ISL), in a healthy person's body over time--called a pharmacokinetic (PK) study. Researchers want to compare the amount of islatravir in the blood when it is taken alone as a single dose and when it is taken with multiple doses of another… 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?
- Islatravir (ISL) and Lamivudine (3TC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 14 Jul 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 55 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 and ≤32 kg/m^2
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
- Is a smoker and/or has used nicotine or nicotine-containing products (for example, nicotine patch and electronic cigarette) within 3 months prior to entering the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Evaluate the Effect of Multiple Doses of Lamivudine on the Single Dose Pharmacokinetics of Islatravir in Healthy Participants
The goal of this study is to learn what happens to the medication islatravir (ISL), in a healthy person's body over time--called a pharmacokinetic (PK) study. Researchers want to compare the amount of islatravir in the blood when it is taken alone as a single dose and when it is taken with multiple doses of another medication called lamivudine (3TC).
- Conditions
- Healthy
- Being tested
- Islatravir (ISL), Lamivudine (3TC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Islatravir (ISL)Drug
Also called MK-8591, ISL
Oral administration of a single dose in period 1 and period 2
Lamivudine (3TC)Drug
Also called 3TC
Oral administration of multiple daily doses for 27 days
| Study group | Role | What they receive |
|---|---|---|
| ISL and 3TC | Experimental | During period 1, participants receive a single dose of islatravir (ISL). During Period 2, participants receive multiple once-daily doses of lamivudine (3TC) for 27 days, and a single dose of ISL co-administered with 3TC on day 6. Receives: Drug: Islatravir (ISL); Drug: Lamivudine (3TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood mononuclear cell (PBMC) Concentration at 168 hours (C168) of islatravir-triphosphate (ISL-TP )
Blood samples will be collected to determine the C168 of ISL-TP
Measured: Predose and at designated timepoints up to 168 hours post dose
PBMC Concentration at 24 Hours (C24) of ISL-TP
Blood samples will be collected to determine the C24 of ISL-TP
Measured: Predose and at designated timepoints up to 24 hours post dose
PBMC Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of ISL-TP
Blood samples will be collected to determine the AUC0-inf of ISL-TP
Measured: Predose and at designated timepoints up to 840 hours post dose
PBMC Area Under the Concentration-time Curve to Time of Last Measurable Concentration (AUClast) of ISL-TP
Blood samples will be collected to determine the AUClast of ISL-TP
Measured: Predose and at designated time points up to 840 hours post dose
PBMC Maximum Concentration (Cmax) of ISL-TP
Blood samples will be collected to determine the Cmax of ISL-TP
Measured: Predose and at designated time points up to 840 hours post dose
PBMC Time to Maximum Concentration (Tmax) of ISL-TP
Blood samples will be collected to determine the Tmax of ISL-TP
Measured: Predose and at designated time points up to 840 hours post dose
PBMC Apparent Terminal Half-life (t1/2) of ISL-TP
Blood samples will be collected to determine the t1/2 of ISL-TP
Measured: Predose and at designated timepoints up to 840 hours post dose
Secondary outcomes (9)
Plasma C168 of ISL
Blood samples will be collected to determine the C168 of ISL
Measured: Predose and at designated timepoints up to 168 hours post dose
Plasma Concentration at 24 Hours (C24) of ISL
Blood samples will be collected to determine the C24 of ISL
Measured: Predose and at designated timepoints up to 24 hours post dose
Plasma AUC0-inf of ISL
Blood samples will be collected to determine the AUC0-inf of ISL
Measured: Predose and at designated timepoints up to 168 hours post dose
Plasma AUClast of ISL
Blood samples will be collected to determine the AUClast of ISL
Measured: Predose and at designated timepoints up to 168 hours post dose
Plasma Cmax of ISL
Blood samples will be collected to determine the Cmax of ISL
Measured: Predose and at designated timepoints up to 168 hours post dose
Plasma Tmax of ISL
Blood samples will be collected to determine the Tmax of ISL-TP
Measured: Predose and at designated timepoints up to 168 hours post dose
Plasma t1/2 of ISL
Blood samples will be collected to determine the t1/2 of ISL
Measured: Predose and at designated timepoints up to 168 hours post dose
Number of Participants Who Experience an Adverse Event (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 who experience an AE will be reported.
Measured: Up to approximately 16 weeks
Number of Participants Who Discontinue Study Treatment 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 who discontinue study treatment due to an AE will be reported
Measured: Up to approximately 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start7 Feb 2024
- Primary completion14 Jul 2024
- Study completion14 Jul 2024
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
- 20 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
- NCT06811246
- Sponsor's protocol ID
- 8591-058
- Other IDs
- MK-8591-058
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Effect of Multiple Doses of Lamivudine on the Single Dose Pharmacokinetics of Islatravir in Healthy Participants
- ClinicalTrials.gov ID
- NCT06811246
- Acronym / sponsor ID
- 8591-058
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 6 Feb 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.
The goal of this study is to learn what happens to the medication islatravir (ISL), in a healthy person's body over time--called a pharmacokinetic (PK) study. Researchers want to compare the amount of islatravir in the blood when it is taken alone as a single dose and when it is taken with multiple doses of another medication called lamivudine (3TC).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISL and 3TC | Experimental | Drug: Islatravir (ISL), Drug: Lamivudine (3TC)During period 1, participants receive a single dose of islatravir (ISL). During Period 2, participants receive multiple once-daily doses of lamivudine (3TC) for 27 days, and a single dose of ISL co-administered with 3TC on day 6. |
Who may qualify
- Ages
- 18 to 55 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 and ≤32 kg/m^2
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
- Is a smoker and/or has used nicotine or nicotine-containing products (for example, nicotine patch and electronic cigarette) within 3 months prior to entering the study
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 |
|---|---|---|
| Islatravir (ISL)Also: MK-8591, ISLOral administration of a single dose in period 1 and period 2 | Drug | ISL and 3TC |
| Lamivudine (3TC)Also: 3TCOral administration of multiple daily doses for 27 days | Drug | ISL and 3TC |
Primary outcome
Peripheral blood mononuclear cell (PBMC) Concentration at 168 hours (C168) of islatravir-triphosphate (ISL-TP )
Time frame: Predose and at designated timepoints up to 168 hours post dose
Blood samples will be collected to determine the C168 of ISL-TP
PBMC Concentration at 24 Hours (C24) of ISL-TP
Time frame: Predose and at designated timepoints up to 24 hours post dose
Blood samples will be collected to determine the C24 of ISL-TP
PBMC Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of ISL-TP
Time frame: Predose and at designated timepoints up to 840 hours post dose
Blood samples will be collected to determine the AUC0-inf of ISL-TP
PBMC Area Under the Concentration-time Curve to Time of Last Measurable Concentration (AUClast) of ISL-TP
Time frame: Predose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the AUClast of ISL-TP
PBMC Maximum Concentration (Cmax) of ISL-TP
Time frame: Predose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the Cmax of ISL-TP
PBMC Time to Maximum Concentration (Tmax) of ISL-TP
Time frame: Predose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the Tmax of ISL-TP
PBMC Apparent Terminal Half-life (t1/2) of ISL-TP
Time frame: Predose and at designated timepoints up to 840 hours post dose
Blood samples will be collected to determine the t1/2 of ISL-TP
9 secondary outcomes
Plasma C168 of ISL
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma Concentration at 24 Hours (C24) of ISL
Time frame: Predose and at designated timepoints up to 24 hours post dose
Plasma AUC0-inf of ISL
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma AUClast of ISL
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma Cmax of ISL
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma Tmax of ISL
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma t1/2 of ISL
Time frame: Predose and at designated timepoints up to 168 hours post dose
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 16 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 10 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 6 Feb 2025.
- 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 Islatravir (ISL) and Lamivudine (3TC) 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 6 Feb 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. 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?
Peripheral blood mononuclear cell (PBMC) Concentration at 168 hours (C168) of islatravir-triphosphate (ISL-TP ) (time frame: Predose and at designated timepoints up to 168 hours post dose). The study lists 7 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 6 Feb 2025.