HealthyPhase 1NCT06893081
A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)
A Phase 1 study testing MK-8527 and CBZ in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-8527 and CBZ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 17 Jul 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a healthy, adult, male or female of non-childbearing potential only, 18-55 years of age, inclusive
- Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
Who cannot join
- Has a history or presence of:
- Seizures (except for febrile seizure), or is at an increased risk for seizures
- Family history of severe dermatologic reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome
- Clinically meaningful hematologic diseases, bone marrow disorders, or hematologic adverse reactions to other medications
- Depression, unusual changes in mood or behavior or suicidal thoughts or behavior
- Hypersensitivity reaction to anticonvulsant therapy (including phenytoin, primidone, and phenobarbital)
Show all 9Show fewer
- Clinically significant eye disease
- Cardiac conduction disturbance, including second-and third-degree atrioventricular heart block
- Shown to carry or be positive for HLA-A*11:01, HLA-A*31:01, HLA-B*15:02, HLA-B*15:08, HLA-B*15:11, HLA-B*15:21, HLA-B*15:30, or HLA-B*15:31 alleles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase 1 Study to Characterize the Effects of a Strong CYP3A4 Inducer on the Pharmacokinetics of MK-8527 in Healthy Adult Participants
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ.
- Conditions
- Healthy
- Being tested
- MK-8527, CBZ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8527Drug
Oral Tablet
CBZDrug
Oral Extended-release Capsule
| Study group | Role | What they receive |
|---|---|---|
| MK-8527 + CBZ | Experimental | Treatment A (Period 1): Participants will receive a single dose of MK-8527 on Day 1.
Treatment B (Period 2): Participants will receive CBZ twice a day on Days 1 to 20 and a single dose of MK-8527 coadministered with the morning dose of CBZ on Day 14.
A washout period will separate Treatments A and B. Receives: Drug: MK-8527; Drug: CBZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-8527
Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 168 hours postdose)
Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-8527
Blood samples will be collected to determine the AUC0-last of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 168 hours postdose)
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8527
Blood samples will be collected to determine the AUC0-24 of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 24 hours postdose)
Area Under the Concentration-Time Curve from 0 to 168 hours (AUC0-168) of MK-8527
Blood samples will be collected to determine the AUC0-168 of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 168 hours postdose)
Maximum Observed Plasma Concentration (Cmax) of MK-8527
Blood samples will be collected to determine the Cmax of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 168 hours postdose)
Time to Maximum Observed Plasma Concentration (Tmax) of MK-8527
Blood samples will be collected to determine the Tmax of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 168 hours postdose)
Apparent Terminal Half-Life (t1/2) of MK-8527
Blood samples will be collected to determine the t1/2 of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 168 hours postdose)
Apparent Clearance (CL/F) of MK-8527
Blood samples will be collected to determine the CL/F of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 168 hours postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
Blood samples will be collected to determine the Vz/F of MK-8527 in plasma
Measured: Predose and at designated timepoints (up to 168 hours postdose)
Secondary outcomes (2)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 60 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start28 Apr 2025
- Primary completion19 Jun 2025
- Study completion17 Jul 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT06893081
- Sponsor's protocol ID
- 8527-012
- Other IDs
- MK-8527-012
- Status last verified
- Jul 2025
- First submitted
- 18 Mar 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1 Study to Characterize the Effects of a Strong CYP3A4 Inducer on the Pharmacokinetics of MK-8527 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06893081
- Acronym / sponsor ID
- 8527-012
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 25 Mar 2025 (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 goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-8527 + CBZ | Experimental | Drug: MK-8527, Drug: CBZTreatment A (Period 1): Participants will receive a single dose of MK-8527 on Day 1. Treatment B (Period 2): Participants will receive CBZ twice a day on Days 1 to 20 and a single dose of MK-8527 coadministered with the morning dose of CBZ on Day 14. A washout period will separate Treatments A and B. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is a healthy, adult, male or female of non-childbearing potential only, 18-55 years of age, inclusive
- Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
Key exclusion criteria (9 listed)
- Has a history or presence of:
- Shown to carry or be positive for HLA-A*11:01, HLA-A*31:01, HLA-B*15:02, HLA-B*15:08, HLA-B*15:11, HLA-B*15:21, HLA-B*15:30, or HLA-B*15:31 alleles.
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-8527Oral Tablet | Drug | MK-8527 + CBZ |
| CBZOral Extended-release Capsule | Drug | MK-8527 + CBZ |
Primary outcome
Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-8527
Time frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma
Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-8527
Time frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the AUC0-last of MK-8527 in plasma
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8527
Time frame: Predose and at designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of MK-8527 in plasma
Area Under the Concentration-Time Curve from 0 to 168 hours (AUC0-168) of MK-8527
Time frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the AUC0-168 of MK-8527 in plasma
Maximum Observed Plasma Concentration (Cmax) of MK-8527
Time frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the Cmax of MK-8527 in plasma
Time to Maximum Observed Plasma Concentration (Tmax) of MK-8527
Time frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the Tmax of MK-8527 in plasma
Apparent Terminal Half-Life (t1/2) of MK-8527
Time frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the t1/2 of MK-8527 in plasma
Apparent Clearance (CL/F) of MK-8527
Time frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the CL/F of MK-8527 in plasma
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
Time frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the Vz/F of MK-8527 in plasma
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 60 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 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 29 Jul 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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-8527 and CBZ 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 9 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 29 Jul 2025. 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 Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-8527 (time frame: Predose and at designated timepoints (up to 168 hours postdose)). The study lists 9 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 29 Jul 2025.