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)
December 2, 2024 updated by: Merck Sharp & Dohme LLC
An Open-Label Study to Evaluate the Effect of a High-Fat Meal on the Pharmacokinetics of Doravirine/Islatravir (100 mg/0.25 mg) Fixed-dose Combination Tablet and to Compare the Pharmacokinetics of Doravirine/Islatravir to Doravirine and Islatravir Single Entities in Healthy Adult Participants
The purpose of this study is to learn what happens to MK-8591A in a person's body over time.
Researchers will compare what happens to MK-8591A in the body when it is given with and without food.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- Celerion (Site 0001)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Inclusion Criteria include, but are not limited to:
- Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
- Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)
Exclusion Criteria:
Exclusion Criteria include, but are not limited to:
- Has a history or presence of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Fixed dose combination tablet
Other Names:
Oral capsule
Other Names:
Oral tablet
Other Names:
|
|
Experimental: 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.
|
Fixed dose combination tablet
Other Names:
Oral capsule
Other Names:
Oral tablet
Other Names:
|
|
Experimental: 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.
|
Fixed dose combination tablet
Other Names:
Oral capsule
Other Names:
Oral tablet
Other Names:
|
|
Experimental: 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.
|
Fixed dose combination tablet
Other Names:
Oral capsule
Other Names:
Oral tablet
Other Names:
|
|
Experimental: 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.
|
Fixed dose combination tablet
Other Names:
Oral capsule
Other Names:
Oral tablet
Other Names:
|
|
Experimental: 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.
|
Fixed dose combination tablet
Other Names:
Oral capsule
Other Names:
Oral tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area under the curve from time 0-infinity (AUC0-inf) of DOR
Time Frame: At designated time points up to ~30 days
|
AUC0-inf is a measure of plasma drug concentration from time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration.
Blood samples collected at designated time points will be used to determine the AUC0-inf of DOR.
|
At designated time points up to ~30 days
|
|
Area under the curve from time 0 to last measurable concentration (AUC0-last) of Doravine
Time Frame: At designated time points up to ~30 days
|
AUC0-last is defined as the area under the concentration-time curve from time 0 to time of last measurable concentration of DOR.
Blood will be collected at designated time points to determine the AUC0-last of DOR.
|
At designated time points up to ~30 days
|
|
Maximum plasma concentration (Cmax) of doravine
Time Frame: At designated time points up to ~30 days
|
Cmax is the maximum concentration of the drug observed in plasma.
Blood samples collected at designated time points will be used to determine Cmax of DOR.
|
At designated time points up to ~30 days
|
|
Plasma concentration at 24 hours postdose (C24) of DOR
Time Frame: At designated time points up to ~24 hours postdose
|
C24 is the concentration at 24 hours postdose of the drug observed in plasma.
Blood samples collected at 24 postdose will be used to determine C24 of DOR.
|
At designated time points up to ~24 hours postdose
|
|
AUC0-inf of ISL
Time Frame: At designated time points up to ~30 days
|
AUC0-inf is a measure of plasma drug concentration and time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration.
Blood samples collected at designated time points will be used to determine the AUC0-inf of ISL.
|
At designated time points up to ~30 days
|
|
AUC0-last of ISL
Time Frame: At designated time points up to ~30 days
|
AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of ISL.
Blood will be collected at designated time points to determine the AUC0-last of ISL.
|
At designated time points up to ~30 days
|
|
Cmax of ISL
Time Frame: At designated time points up to ~30 days
|
Cmax is the maximum concentration of the drug observed in plasma.
Blood samples collected at designated time points will be used to determine Cmax of ISL.
|
At designated time points up to ~30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who experienced an adverse event (AE)
Time Frame: Up to ~44 days
|
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
The number of participants with an adverse event will be reported.
|
Up to ~44 days
|
|
Number of participants who discontinued study intervention due to an AE
Time Frame: Up to ~30 days
|
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
The number of participants who discontinue study intervention due to an AE will be reported.
|
Up to ~30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2024
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
March 15, 2024
Study Registration Dates
First Submitted
December 2, 2024
First Submitted That Met QC Criteria
December 2, 2024
First Posted (Estimated)
December 6, 2024
Study Record Updates
Last Update Posted (Estimated)
December 6, 2024
Last Update Submitted That Met QC Criteria
December 2, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8591A-055
- MK-8591A-055 (Other Identifier: MSD)
- CA42943 (Other Identifier: Celerion)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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