Examining how MK-8527 affects healthy lactating women and their breast milk
A Clinical Study to Evaluate the Breast Milk, Plasma and Whole Blood Pharmacokinetics of MK-8527 in Healthy Lactating Female Participants
This study tests how the drug MK-8527 affects healthy breastfeeding women and their breast milk to see if it's safe for them and their babies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06580587 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics of MK-8527 in healthy lactating women, focusing on how the drug is processed in the body and its presence in breast milk. Participants must be at least 6 weeks postpartum and will express breast milk multiple times over a period of 120 hours after receiving the drug. The study aims to ensure that the infants are safely fed with alternative nutrition during the study period, as breastfeeding will be temporarily discontinued. The findings could provide valuable insights into the safety of MK-8527 for breastfeeding mothers and their infants.
Who should consider this trial
Good fit: Ideal candidates are healthy lactating women who are at least 6 weeks postpartum and can express breast milk.
Not a fit: Patients who are not lactating or who have health conditions that contraindicate participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help establish the safety of MK-8527 for lactating women and inform guidelines for HIV prevention in this population.
How similar studies have performed: While studies on drug safety in lactating women are common, the specific focus on MK-8527 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh Medical Center Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.