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

Phase 1Active Not RecruitingNCT07086079

Merck Sharp & Dohme LLC12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

12

Conditions

Interventions

Oral tablet

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

QPS Missouri ( Site 0001)

Springfield, Missouri, United States

Outcomes

Primary Outcomes

Cumulative Amount of DOR Excreted in Breast Milk From 0 to 24 Hours (Ae0-24hrs)

Breast milk samples will be collected to determine the Ae0-24hrs after administration of DOR.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Body Weight Normalized Infant Theoretical Dose of DOR

Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of DOR as normalized by participant-reported infant body weight.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Relative Infant Theoretical Dose of DOR

Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of DOR relative to the maternal dose.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Cumulative Amount of Total ISL Excreted in Breast Milk From 0 to 24 Hours (Ae0-24hrs)

Breast milk samples will be collected to determine the Ae0-24hrs after administration of total ISL.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Body Weight Normalized Infant Theoretical Dose of ISL

Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of ISL as normalized by participant-reported infant body weight.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Relative Infant Theoretical Dose of ISL

Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of ISL relative to the maternal dose.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Secondary Outcomes

Data from ClinicalTrials.gov

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Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24hrs) of DOR in Breast Milk

Breast milk samples will be collected to determine the AUC0-24hrs of DOR.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Maximum Concentration (Cmax) of DOR in Breast Milk

Breast milk samples will be collected to determine the Cmax of DOR.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Time to Maximum Concentration (Tmax) of DOR in Breast Milk

Breast milk samples will be collected to determine the Tmax of DOR

Time frame: Predose and at designated timepoints up to 24 hours postdose

AUC0-24hrs of Total ISL in Breast Milk

Breast milk samples will be collected to determine the AUC0-24hrs of total ISL.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Cmax of Total ISL in Breast Milk

Breast milk samples will be collected to determine the Cmax of total ISL.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Tmax of Total ISL in Breast Milk

Breast milk samples will be collected to determine the Tmax of total ISL.

Time frame: Predose and at designated timepoints up to 24 hours postdose

AUC0-24hrs of DOR in Plasma

Plasma samples will be collected to determine the AUC0-24hrs of DOR.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Cmax of DOR in Plasma

Plasma samples will be collected to determine the Cmax of DOR.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Tmax of DOR in Plasma

Plasma samples will be collected to determine the Tmax of DOR.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Concentration at 24 Hours (C24) of DOR in Plasma

Plasma samples will be collected to determine the C24 of DOR.

Time frame: Predose and at designated timepoints up to 24 hours postdose

AUC0-24hrs of ISL in Plasma

Plasma samples will be collected to determine the AUC0-24hrs of ISL.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Cmax of ISL in Plasma

Plasma samples will be collected to determine the Cmax of ISL.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Tmax of ISL in Plasma

Plasma samples will be collected to determine the Tmax of ISL.

Time frame: Predose and at designated timepoints up to 24 hours postdose

C24 of ISL in Plasma

Plasma samples will be collected to determine the C24 of ISL.

Time frame: Predose and at designated timepoints up to 24 hours postdose

NCT07086079 - A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061) | Crick | Crick