A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055)
NCT ID: NCT06719570
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2024-01-23
2024-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MK-8591A Sequence 1A
Participants will receive Doravine/Islatravir (DOR/ISL) fixed-dose combination (FDC) tablet under fasting conditions followed by a DOR/ISL FDC tablet under fed conditions followed by a single dose Doravine tablet and a single dose Islatravir capsule under fasting conditions.
MK-8591A
Fixed dose combination tablet
Islatravir
Oral capsule
Doravine
Oral tablet
MK-8591A Sequence 2A
Participants will receive DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions.
MK-8591A
Fixed dose combination tablet
Islatravir
Oral capsule
Doravine
Oral tablet
MK-8591A Sequence 1B
Participants will receive DOR/ISL FDC tablet under fed conditions followed by a DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions.
MK-8591A
Fixed dose combination tablet
Islatravir
Oral capsule
Doravine
Oral tablet
MK-8591A Sequence 2B
Participants will receive DOR/ISL FDC tablet under fed conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting condition followed by a DOR/ISL FDC tablet under fasting conditions.
MK-8591A
Fixed dose combination tablet
Islatravir
Oral capsule
Doravine
Oral tablet
MK-8591A Sequence 1C
Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fasting conditions followed by followed by a DOR/ISL FDC tablet under fed conditions.
MK-8591A
Fixed dose combination tablet
Islatravir
Oral capsule
Doravine
Oral tablet
MK-8591A Sequence 2C
Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions followed by followed by a DOR/ISL FDC tablet under fasting conditions.
MK-8591A
Fixed dose combination tablet
Islatravir
Oral capsule
Doravine
Oral tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MK-8591A
Fixed dose combination tablet
Islatravir
Oral capsule
Doravine
Oral tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)
Exclusion Criteria
* Has a history of cancer (malignancy)
19 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Celerion (Site 0001)
Lincoln, Nebraska, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK-8591A-055
Identifier Type: OTHER
Identifier Source: secondary_id
CA42943
Identifier Type: OTHER
Identifier Source: secondary_id
8591A-055
Identifier Type: -
Identifier Source: org_study_id