Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06580587 · ClinicalTrials.gov registry record · Phase 1
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
A Phase 1 study of Healthy and HIV Pre-exposure Prophylaxis, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT06580587: Active Phase 1 study of Healthy and HIV Pre-exposure Prophylaxis, sponsored by Merck Sharp & Dohme.
NCT06580587 is a Phase 1 study of Healthy and HIV Pre-exposure Prophylaxis that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 12 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06580587, a Phase 1 study of Healthy and HIV Pre-exposure Prophylaxis, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Breast milk samples will be collected to determine the AUC0-120hrs after administration of a single oral dose of MK-8527.
Conditions Studied
Interventions
- DRUG MK-8527
Study Locations (2)
Missouri
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002) - Springfield
Pennsylvania
- University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-04-15 |
| Est. Completion | 2026-03-27 |
| Phase | Phase 1 |
What the registry record for NCT06580587 still lists
NCT06580587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which MK-8527 is the first listed.
NCT06580587 reports a single indexed study location in Missouri, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06580587 about?
NCT06580587 is a clinical study titled "A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)". 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.
What is the current status of trial NCT06580587?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-04-15. Estimated completion is 2026-03-27.
What conditions does trial NCT06580587 study?
This clinical trial studies the following conditions: Healthy, HIV Pre-exposure Prophylaxis.
What interventions are being tested in trial NCT06580587?
The interventions under investigation include: MK-8527 (DRUG).
Who is sponsoring clinical trial NCT06580587?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06580587 being conducted?
This trial has 2 study locations across Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06580587's enrollment target sits among peer trials
12 996th of 1090 higher than 61 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
RECRUITING · Phase 1
-
A Study of LY3867070 in Healthy Participants
RECRUITING · Phase 1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
RECRUITING · Phase 1
-
Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
RECRUITING · Phase 1
-
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
RECRUITING · Phase 1
-
A Study of V118E in Healthy Participants (V118E-003)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI