HealthyPhase 1NCT06580587
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
A Phase 1 study testing MK-8527 in people with Healthy and HIV Pre-exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 2 sites in United States.
Trial summary
The goal of this study is to learn how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, HIV Pre-exposure Prophylaxis
- What is being tested?
- MK-8527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2025to 27 Mar 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The key inclusion criteria include but are not limited to the following:
- Is at least 6 weeks postpartum at the time of administration of study intervention, following the delivery of a healthy singleton neonate
- Is willing and able to express breast milk at least twice daily for at least 120 hours after enrollment
- Is willing to discontinue breastfeeding from the time of administration of study intervention until at least 6 weeks following the administration of study intervention. This includes the avoidance of both directly breastfeeding and the administration of breast milk pumped during the above-specified time frame to the infant. Is willing to confirm with the site that the infant is able to bottle feed (breast milk) prior to Day 1 and that alternative nutrition (i.e., previously stored breast milk or infant formula) is available for feeding the infant through the 6-week post dose period
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, psychiatric, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Had mastitis within 30 days prior to administration of study drug
- Has a positive pregnancy test at the time of screening or prior to treatment allocation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001)
Pittsburgh, Pennsylvania, 15213
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)
Springfield, Missouri, 65802
About this study
Official title: A Clinical Study to Evaluate the Breast Milk, Plasma and Whole Blood Pharmacokinetics of MK-8527 in Healthy Lactating Female Participants
The goal of this study is to learn how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points.
- Conditions
- Healthy, HIV Pre-exposure Prophylaxis
- Being tested
- MK-8527
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8527Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| MK-8527 | Experimental | Participants receive single oral dose of MK-8527 on Day 1 Receives: Drug: MK-8527 |
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 120 hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Breast Milk
Breast milk samples will be collected to determine the AUC0-120hrs after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 120 hours postdose
Maximum Breast Milk Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
Breast milk samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 21 days postdose
Time to Maximum Breast Milk Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
Breast milk samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 21 days postdose
Secondary outcomes (12)
Mean Concentration of MK-8527 in Breast Milk After Administration of a Single Oral Dose
Breast milk samples will be collected to determine the mean concentration of MK-8527.
Measured: Predose and at designated timepoints up to 120 hours postdose
Amount Excreted in Breast Milk From Time Zero to 120 Hours (Ae0-120hrs) After Administration of a Single Oral Dose of MK-8527
Breast milk samples will be collected to determine the Ae0-120hrs after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 to 120 hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Blood
Blood samples will be collected to determine AUC0-120hrs after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Time-Infinity (AUC0-Inf) After Administration of a Single Oral Dose of MK-8527 in Blood
Blood samples will be collected to determine AUC0-inf after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 21 days postdose
Maximum Blood Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
Blood samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 21 days postdose
Time to Maximum Blood Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
Blood samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 21 days postdose
Area Under the Concentration-Time Curve from Time 0 to 120hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Plasma
Plasma samples will be collected to determine AUC0-120hrs after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Time-Infinity (AUC0-Inf) After Administration of a Single Oral Dose of MK-8527 in Plasma
Plasma samples will be collected to determine AUC0-inf.
Measured: Predose and at designated timepoints up to 7 days postdose
Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
Plasma samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 7 days postdose
Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
Plasma samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.
Measured: Predose and at designated timepoints up to 7 days postdose
Ratio of MK-8527 in Breast Milk to Blood After Administration of a Single Dose of MK-8527
Ratio of MK-8527 in breast milk to blood will be used to estimate dose of MK-8527.
Measured: At designated timepoints up to 120 hours postdose
Ratio of MK-8527 in Breast Milk to Plasma After Administration of a Single Oral Dose
Ratio of MK-8527 in breast milk to plasma will be used to estimate dose of MK-8527.
Measured: At designated timepoints up to 120 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start15 Apr 2025
- Primary completion27 Mar 2026
- Study completion27 Mar 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
- 13 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
- NCT06580587
- Sponsor's protocol ID
- 8527-009
- Other IDs
- MK-8527-009
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2024
- Last updated
- 16 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Breast Milk, Plasma and Whole Blood Pharmacokinetics of MK-8527 in Healthy Lactating Female Participants
- ClinicalTrials.gov ID
- NCT06580587
- Acronym / sponsor ID
- 8527-009
- Conditions
- Healthy, HIV Pre-exposure Prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 30 Aug 2024 (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 how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-8527 | Experimental | Drug: MK-8527Participants receive single oral dose of MK-8527 on Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is at least 6 weeks postpartum at the time of administration of study intervention, following the delivery of a healthy singleton neonate
- Is willing and able to express breast milk at least twice daily for at least 120 hours after enrollment
- Is willing to discontinue breastfeeding from the time of administration of study intervention until at least 6 weeks following the administration of study intervention. This includes the avoidance of both directly breastfeeding and the administration of breast milk pumped during the above-specified time frame to the infant. Is willing to confirm with the site that the infant is able to bottle feed (breast milk) prior to Day 1 and that alternative nutrition (i.e., previously stored breast milk or infant formula) is available for feeding the infant through the 6-week post dose period
Key exclusion criteria (4 listed)
- 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, psychiatric, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Had mastitis within 30 days prior to administration of study drug
- Has a positive pregnancy test at the time of screening or prior to treatment allocation
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 |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to 120 hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Breast Milk
Time frame: Predose and at designated timepoints up to 120 hours postdose
Breast milk samples will be collected to determine the AUC0-120hrs after administration of a single oral dose of MK-8527.
Maximum Breast Milk Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
Time frame: Predose and at designated timepoints up to 21 days postdose
Breast milk samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.
Time to Maximum Breast Milk Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
Time frame: Predose and at designated timepoints up to 21 days postdose
Breast milk samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.
12 secondary outcomes
Mean Concentration of MK-8527 in Breast Milk After Administration of a Single Oral Dose
Time frame: Predose and at designated timepoints up to 120 hours postdose
Amount Excreted in Breast Milk From Time Zero to 120 Hours (Ae0-120hrs) After Administration of a Single Oral Dose of MK-8527
Time frame: Predose and at designated timepoints up to 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 to 120 hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Blood
Time frame: Predose and at designated timepoints up to 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Time-Infinity (AUC0-Inf) After Administration of a Single Oral Dose of MK-8527 in Blood
Time frame: Predose and at designated timepoints up to 21 days postdose
Maximum Blood Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
Time frame: Predose and at designated timepoints up to 21 days postdose
Time to Maximum Blood Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
Time frame: Predose and at designated timepoints up to 21 days postdose
Area Under the Concentration-Time Curve from Time 0 to 120hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Plasma
Time frame: Predose and at designated timepoints up to 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Time-Infinity (AUC0-Inf) After Administration of a Single Oral Dose of MK-8527 in Plasma
Time frame: Predose and at designated timepoints up to 7 days postdose
Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
Time frame: Predose and at designated timepoints up to 7 days postdose
Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
Time frame: Predose and at designated timepoints up to 7 days postdose
Ratio of MK-8527 in Breast Milk to Blood After Administration of a Single Dose of MK-8527
Time frame: At designated timepoints up to 120 hours postdose
Ratio of MK-8527 in Breast Milk to Plasma After Administration of a Single Oral Dose
Time frame: At designated timepoints up to 120 hours postdose
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 16 Apr 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
2 sites 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 in people with Healthy and HIV Pre-exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 2 sites 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 4 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 16 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 2 sites 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 120 hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Breast Milk (time frame: Predose and at designated timepoints up to 120 hours postdose). 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 16 Apr 2026.