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

NCT ID: NCT07086079

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-26

Study Completion Date

2025-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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DOR/ISL

Participants will receive DOR/ISL as an oral fixed-dose combination tablet once daily on Days 1 to 7.

Group Type EXPERIMENTAL

DOR/ISL

Intervention Type DRUG

Oral tablet

Interventions

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DOR/ISL

Oral tablet

Intervention Type DRUG

Other Intervention Names

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MK-8591A

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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QPS Missouri ( Site 0001)

Springfield, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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8591A-061

Identifier Type: -

Identifier Source: org_study_id

MK-8591A-061

Identifier Type: OTHER

Identifier Source: secondary_id