HIV-1Phase 1NCT05700734
MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
A Phase 1 study testing MK-8510 in people with HIV-1 and Human Immunodeficiency Virus 1, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1, Human Immunodeficiency Virus 1, Immunodeficiency Virus Type 1, Human
- What is being tested?
- MK-8510
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2023to 14 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has HIV-1 infection, and is in good health based on medical history, physical examination, vital signs (VS) measurements, and laboratory safety tests.
- Has documented HIV-1 positive, as determined by a positive enzyme-linked immunosorbent assay (ELISA) or real-time quantitative polymerase chain reaction (QT-PCR) with confirmation (eg, Western Blot).
- Is anti-retroviral therapy (ART)-naïve, which is defined as:
- Having never received any anti-retroviral agent; or
- ART-experienced but has not received any ART for HIV-1 infection within 60 days; or
- Has received pre-exposure prophylaxis (PrEP) treatment prior to diagnosis of HIV-infection but has not received any PrEP within 30 days.
- Is willing to receive no other ART prior to Day 11 post-dose of the study.
- Has a body mass index (BMI) ≤35 kg/m2.
Who cannot join
- Has acute (primary) HIV-1 infection.
- 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 remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma).
- Is mentally or legally incapacitated or has significant emotional problems.
- Has history of cancer (malignancy).
- Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e, systemic allergic reaction) to prescription or nonprescription drugs or food.
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- Has positive hepatitis B surface antigen (HBsAg).
- Has a history of chronic hepatitis C unless there has been documented cure and/or participant with a positive serologic test for hepatitis C virus (HCV) has a negative HCV viral load (VL).
- Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- Has participated in another investigational study within 4 weeks.
- Has a clinically significant abnormality on the electrocardiogram (ECG) performed at the pre-study visit.
- Has been committed to an institution by way of official or judicial order.
- Is under the age of legal consent or not capable of giving consent.
- Does not agree to follow the smoking restrictions as defined by the clinical research unit (CRU).
- Consumes greater than 3 servings of alcoholic beverages (1 serving is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day.
- Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Is a regular user of any illicit drugs (not including cannabis) or has an history of drug (including alcohol) abuse within approximately 12 months.
About this study
Official title: A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-retroviral Activity of MK-8510 Monotherapy in Anti-retroviral-naïve HIV-1 Infected Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.
- Conditions
- HIV-1, Human Immunodeficiency Virus 1, Immunodeficiency Virus Type 1, Human, Human Immunodeficiency Virus Type 1
- Being tested
- MK-8510
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8510Drug
Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Panel A: MK-8510 at dose level 1 | Experimental | Single oral dose of MK-8510 administered at dose level 1 (≤1800 mg) following a 10-hour fast. Dose level 1 shall not exceed 1800 mg. Receives: Drug: MK-8510 |
| Panel B: MK-8510 at dose level 2 | Experimental | Single oral dose of MK-8510 administered at dose level 2 (≤2200 mg) following a 10-hour fast. Dose level 2 shall not exceed 2200 mg. Receives: Drug: MK-8510 |
| Panel C: MK-8510 at dose level 3 | Experimental | Single oral dose of MK-8510 administered at dose level 3 (≤2200 mg) following a 10-hour fast. Dose level 3 shall not exceed 2200 mg. Receives: Drug: MK-8510 |
| Panel D: MK-8510 at dose level 4 | Experimental | Single oral dose of MK-8510 administered at dose level 4 (≤2200 mg) following a 10-hour fast. Dose level 4 shall not exceed 2200 mg. Receives: Drug: MK-8510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
The plasma HIV-RNA will be measured based on a longitudinal data analysis model containing fixed effects for dose level, and dose level by time interaction, and a random effect of MK-8510 (prodrug). The change from baseline for each dose level at 168-hours post baseline will be estimated from this model.
Measured: Baseline and 168 hours post-dose
Percentage of Participants Who Experience an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to 36 days
Percentage of Participants Who Discontinued from Study Due to an Adverse Event (AE)
The percentage of participants who discontinue study due to an AE will be presented.
Measured: Up to 36 days
Secondary outcomes (9)
Area Under the Concentration-Time Curve of MK-8558 From Time 0 to 168 Hours (AUC0-168 hr)
The AUC0-168 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168 hours post-dose.
Measured: At protocol specific timepoints up to 168 hours post-dose
Area Under the Concentration-Time Curve of MK-8558 From Time 0 to last (AUC0-last)
AUC0-last of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Measured: At protocol specific time points up to 504 hours post-dose
Concentration at 168 Hours Post-dose (C168) of MK-8558
C168hr of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated.
Measured: 168 hours post-dose
Maximum Concentration (Cmax) of MK-8558
Cmax of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Measured: At protocol specific time points up to 504 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of MK-8558
Tmax of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Measured: At protocol specific time points up to 504 hours post-dose
Half Life (t1/2) of MK-8558
t1/2 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Measured: At protocol specific time points up to 504 hours post-dose
Apparent Plasma Clearance of Drug After Extravascular Administration (CL/F) of MK-8558
CL/F of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Measured: At protocol specific time points up to 504 hours post-dose
Apparent Volume of Distribution in the Terminal State After Extravascular Administration (Vz/F) of MK-8558
Vz/F of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Measured: At protocol specific time points up to 504 hours post-dose
Terminal t1/2 of MK-8558
Terminal t1/2 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Measured: At protocol specific time points up to 504 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start17 Apr 2023 (estimated)
- Primary completion14 Feb 2024 (estimated)
- Study completion14 Feb 2024 (estimated)
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT05700734
- Sponsor's protocol ID
- 8510-002
- Other IDs
- MK-8510-002, 2021-006180-21
- Status last verified
- Mar 2023
- First submitted
- 17 Jan 2023
- Last updated
- 27 Mar 2023
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-retroviral Activity of MK-8510 Monotherapy in Anti-retroviral-naïve HIV-1 Infected Participants
- ClinicalTrials.gov ID
- NCT05700734
- Acronym / sponsor ID
- 8510-002
- Conditions
- HIV-1, Human Immunodeficiency Virus 1, Immunodeficiency Virus Type 1, Human, Human Immunodeficiency Virus Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (estimated)
- Primary completion
- 14 Feb 2024 (estimated)
- Study completion
- 14 Feb 2024 (estimated)
- First posted
- 26 Jan 2023 (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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panel A: MK-8510 at dose level 1 | Experimental | Drug: MK-8510Single oral dose of MK-8510 administered at dose level 1 (≤1800 mg) following a 10-hour fast. Dose level 1 shall not exceed 1800 mg. |
| Panel B: MK-8510 at dose level 2 | Experimental | Drug: MK-8510Single oral dose of MK-8510 administered at dose level 2 (≤2200 mg) following a 10-hour fast. Dose level 2 shall not exceed 2200 mg. |
| Panel C: MK-8510 at dose level 3 | Experimental | Drug: MK-8510Single oral dose of MK-8510 administered at dose level 3 (≤2200 mg) following a 10-hour fast. Dose level 3 shall not exceed 2200 mg. |
| Panel D: MK-8510 at dose level 4 | Experimental | Drug: MK-8510Single oral dose of MK-8510 administered at dose level 4 (≤2200 mg) following a 10-hour fast. Dose level 4 shall not exceed 2200 mg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Has HIV-1 infection, and is in good health based on medical history, physical examination, vital signs (VS) measurements, and laboratory safety tests.
- Has documented HIV-1 positive, as determined by a positive enzyme-linked immunosorbent assay (ELISA) or real-time quantitative polymerase chain reaction (QT-PCR) with confirmation (eg, Western Blot).
- Is anti-retroviral therapy (ART)-naïve, which is defined as:
- Is willing to receive no other ART prior to Day 11 post-dose of the study.
- Has a body mass index (BMI) ≤35 kg/m2.
Key exclusion criteria (17 listed)
- Has acute (primary) HIV-1 infection.
- 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 remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma).
- Is mentally or legally incapacitated or has significant emotional problems.
- Has history of cancer (malignancy).
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-8510Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg. | Drug | Panel A: MK-8510 at dose level 1, Panel B: MK-8510 at dose level 2, Panel C: MK-8510 at dose level 3, Panel D: MK-8510 at dose level 4 |
Primary outcome
Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
Time frame: Baseline and 168 hours post-dose
The plasma HIV-RNA will be measured based on a longitudinal data analysis model containing fixed effects for dose level, and dose level by time interaction, and a random effect of MK-8510 (prodrug). The change from baseline for each dose level at 168-hours post baseline will be estimated from this model.
Percentage of Participants Who Experience an Adverse Event (AE)
Time frame: Up to 36 days
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Percentage of Participants Who Discontinued from Study Due to an Adverse Event (AE)
Time frame: Up to 36 days
The percentage of participants who discontinue study due to an AE will be presented.
9 secondary outcomes
Area Under the Concentration-Time Curve of MK-8558 From Time 0 to 168 Hours (AUC0-168 hr)
Time frame: At protocol specific timepoints up to 168 hours post-dose
Area Under the Concentration-Time Curve of MK-8558 From Time 0 to last (AUC0-last)
Time frame: At protocol specific time points up to 504 hours post-dose
Concentration at 168 Hours Post-dose (C168) of MK-8558
Time frame: 168 hours post-dose
Maximum Concentration (Cmax) of MK-8558
Time frame: At protocol specific time points up to 504 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of MK-8558
Time frame: At protocol specific time points up to 504 hours post-dose
Half Life (t1/2) of MK-8558
Time frame: At protocol specific time points up to 504 hours post-dose
Apparent Plasma Clearance of Drug After Extravascular Administration (CL/F) of MK-8558
Time frame: At protocol specific time points up to 504 hours post-dose
Apparent Volume of Distribution in the Terminal State After Extravascular Administration (Vz/F) of MK-8558
Time frame: At protocol specific time points up to 504 hours post-dose
Terminal t1/2 of MK-8558
Time frame: At protocol specific time points up to 504 hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-8510 in people with HIV-1 and Human Immunodeficiency Virus 1, run by Merck Sharp & Dohme LLC.
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 8 inclusion and 17 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: withdrawn, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Plasma HIV-1 Ribonucleic Acid (RNA) (time frame: Baseline and 168 hours post-dose). 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 27 Mar 2023.