A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061)

Merck Sharp & Dohme (MSD)

Status and phase

Begins enrollment in 1 month

Phase 1

Conditions

Healthy

Treatments

Drug: DOR/ISL

Study type

Interventional

Funder types

Industry

Identifiers

NCT07086079

MK-8591A-061 (Other Identifier)

8591A-061

Details and patient eligibility

About

The goal of this study is to learn what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time. Researchers want to learn if DOR and ISL are in breast milk.

Enrollment

12 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

Is at least 6-weeks postpartum at the time of administration of study drug, following the delivery of a healthy singleton neonate
Is willing and able to express breast milk using an electric pump prior to study drug administration and is expected to be able to express at least 4 times over a 24-hour period after study drug administration

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, psychiatric, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Has had mastitis within 30 days prior to administration of study drug