HealthyPhase 1NCT06719570
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)
A Phase 1 study testing MK-8591A, Islatravir and Doravine in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-8591A, Islatravir and Doravine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2024to 15 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- MK-8591A, Islatravir, Doravine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8591ADrug
Also called Doravirine/Islatravir (DOR/ISL) Fixed-Dose Combination (FDC)
Fixed dose combination tablet
IslatravirDrug
Also called MK-8591, ISL
Oral capsule
DoravineDrug
Also called MK-1439, DOR
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| MK-8591A Sequence 1A | Experimental | 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. Receives: Drug: MK-8591A; Drug: Islatravir; Drug: Doravine |
| MK-8591A Sequence 2A | Experimental | 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. Receives: Drug: MK-8591A; Drug: Islatravir; Drug: Doravine |
| MK-8591A Sequence 1B | Experimental | 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. Receives: Drug: MK-8591A; Drug: Islatravir; Drug: Doravine |
| MK-8591A Sequence 2B | Experimental | 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. Receives: Drug: MK-8591A; Drug: Islatravir; Drug: Doravine |
| MK-8591A Sequence 1C | Experimental | 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. Receives: Drug: MK-8591A; Drug: Islatravir; Drug: Doravine |
| MK-8591A Sequence 2C | Experimental | 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. Receives: Drug: MK-8591A; Drug: Islatravir; Drug: Doravine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time 0-infinity (AUC0-inf) of DOR
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.
Measured: At designated time points up to ~30 days
Area under the curve from time 0 to last measurable concentration (AUC0-last) of Doravine
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.
Measured: At designated time points up to ~30 days
Maximum plasma concentration (Cmax) of doravine
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.
Measured: At designated time points up to ~30 days
Plasma concentration at 24 hours postdose (C24) of DOR
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.
Measured: At designated time points up to ~24 hours postdose
AUC0-inf of ISL
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.
Measured: At designated time points up to ~30 days
AUC0-last of ISL
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.
Measured: At designated time points up to ~30 days
Cmax of ISL
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.
Measured: At designated time points up to ~30 days
Secondary outcomes (2)
Number of participants who experienced an adverse event (AE)
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.
Measured: Up to ~44 days
Number of participants who discontinued study intervention due to an AE
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.
Measured: Up to ~30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start23 Jan 2024
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719570
- Sponsor's protocol ID
- 8591A-055
- Other IDs
- MK-8591A-055, CA42943
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06719570
- Acronym / sponsor ID
- 8591A-055
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MK-8591A Sequence 1A | Experimental | Drug: MK-8591A, Drug: Islatravir, Drug: DoravineParticipants 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 Sequence 2A | Experimental | Drug: MK-8591A, Drug: Islatravir, Drug: DoravineParticipants 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 Sequence 1B | Experimental | Drug: MK-8591A, Drug: Islatravir, Drug: DoravineParticipants 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 Sequence 2B | Experimental | Drug: MK-8591A, Drug: Islatravir, Drug: DoravineParticipants 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 Sequence 1C | Experimental | Drug: MK-8591A, Drug: Islatravir, Drug: DoravineParticipants 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 Sequence 2C | Experimental | Drug: MK-8591A, Drug: Islatravir, Drug: DoravineParticipants 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. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-8591AAlso: Doravirine/Islatravir (DOR/ISL) Fixed-Dose Combination (FDC)Fixed dose combination tablet | Drug | MK-8591A Sequence 1A, MK-8591A Sequence 1B, MK-8591A Sequence 1C, MK-8591A Sequence 2A, MK-8591A Sequence 2B, MK-8591A Sequence 2C |
| IslatravirAlso: MK-8591, ISLOral capsule | Drug | MK-8591A Sequence 1A, MK-8591A Sequence 1B, MK-8591A Sequence 1C, MK-8591A Sequence 2A, MK-8591A Sequence 2B, MK-8591A Sequence 2C |
| DoravineAlso: MK-1439, DOROral tablet | Drug | MK-8591A Sequence 1A, MK-8591A Sequence 1B, MK-8591A Sequence 1C, MK-8591A Sequence 2A, MK-8591A Sequence 2B, MK-8591A Sequence 2C |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Number of participants who experienced an adverse event (AE)
Time frame: Up to ~44 days
Number of participants who discontinued study intervention due to an AE
Time frame: Up to ~30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-8591A, Islatravir and Doravine in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve from time 0-infinity (AUC0-inf) of DOR (time frame: At designated time points up to ~30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.