HealthyPhase 1NCT06649877
MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013)
A Phase 1 study testing MK-6194 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-6194 in a healthy person's body when different injection sites are used. Researchers will compare what happens to MK-6194 in a healthy person's body when it is injected into the abdomen and when it is injected into the thigh. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-6194
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 13 Jul 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The key inclusion criteria include but are not limited to the following:
- Is in good health
- Has a body mass index (BMI) within 18 to 35 kg/m2 and weighs at least 50 kg
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
QPS-MRA, LLC-Early Phase (Site 0001)
South Miami, Florida, 33143
About this study
Official title: A Randomized Clinical Study to Evaluate the Impact of Injection Site (Thigh vs Abdomen) on the Pharmacokinetics and Relative Bioavailability of Subcutaneously Injected MK-6194 in Healthy Adult Participants
The goal of this study is to learn what happens to MK-6194 in a healthy person's body when different injection sites are used. Researchers will compare what happens to MK-6194 in a healthy person's body when it is injected into the abdomen and when it is injected into the thigh. Researchers think that the average amount of MK-6194 in a person's body over time will be similar when injected into the thigh or abdomen. They also want to learn if it is safe to inject MK-6194 into the abdomen and thigh, and if people tolerate it.
- Conditions
- Healthy
- Being tested
- MK-6194
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6194Biological
Also called PT101
single injected dose
| Study group | Role | What they receive |
|---|---|---|
| Abdomen Injection | Experimental | Participants will receive a single dose of MK-6194 injected into the abdomen. Receives: Biological: MK-6194 |
| Thigh Injection | Experimental | Participants will receive a single dose of MK-6194 injected into the thigh. Receives: Biological: MK-6194 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194
Blood samples will be collected to determine the AUC0-Last of MK-6194.
Measured: At designated timepoints (up to approximately 4 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194
Blood samples will be collected to determine the AUC0-Inf of MK-6194.
Measured: At designated timepoints (up to approximately 4 weeks postdose)
Maximum Plasma Concentration (Cmax) of MK-6194
Blood samples will be collected to determine the Cmax of MK-6194.
Measured: At designated timepoints (up to approximately 4 weeks postdose)
Time to Maximum Plasma Concentration (Tmax) of MK-6194
Blood samples will be collected to determine the Tmax of MK-6194.
Measured: At designated timepoints (up to approximately 4 weeks postdose)
Apparent Clearance (CL/F) of MK-6194
Blood samples will be collected to determine the CL/F of MK-6194.
Measured: At designated timepoints (up to approximately 4 weeks postdose)
Apparent Terminal Half-life (t1/2) of MK-6194
Blood samples will be collected to determine the t1/2 of MK-6194.
Measured: At designated timepoints (up to approximately 4 weeks postdose)
Apparent Volume of Distribution (Vz/F) of MK-6194
Blood samples will be collected to determine the Vz/F of MK-6194.
Measured: At designated timepoints (up to approximately 4 weeks postdose)
Secondary outcomes (2)
Number of Participants Who Experience an Adverse Event
An adverse event (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. The number of participants who experience an AE will be reported.
Measured: Up to approximately 12 weeks
Number of Participants Who Discontinue Study 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. The number of participants who discontinue study due to an AE will be reported.
Measured: Up to approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start20 Mar 2023
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
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
- 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
- NCT06649877
- Sponsor's protocol ID
- 6194-013
- Other IDs
- MK-6194-013
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 21 Oct 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study to Evaluate the Impact of Injection Site (Thigh vs Abdomen) on the Pharmacokinetics and Relative Bioavailability of Subcutaneously Injected MK-6194 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06649877
- Acronym / sponsor ID
- 6194-013
- 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
- 20 Mar 2023 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 21 Oct 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 goal of this study is to learn what happens to MK-6194 in a healthy person's body when different injection sites are used. Researchers will compare what happens to MK-6194 in a healthy person's body when it is injected into the abdomen and when it is injected into the thigh. Researchers think that the average amount of MK-6194 in a person's body over time will be similar when injected into the thigh or abdomen. They also want to learn if it is safe to inject MK-6194 into the abdomen and thigh, and if people tolerate it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdomen Injection | Experimental | Biological: MK-6194Participants will receive a single dose of MK-6194 injected into the abdomen. |
| Thigh Injection | Experimental | Biological: MK-6194Participants will receive a single dose of MK-6194 injected into the thigh. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Has a body mass index (BMI) within 18 to 35 kg/m2 and weighs at least 50 kg
Key exclusion criteria (3 listed)
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer
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-6194Also: PT101single injected dose | Biological | Abdomen Injection, Thigh Injection |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194
Time frame: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the AUC0-Last of MK-6194.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194
Time frame: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the AUC0-Inf of MK-6194.
Maximum Plasma Concentration (Cmax) of MK-6194
Time frame: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the Cmax of MK-6194.
Time to Maximum Plasma Concentration (Tmax) of MK-6194
Time frame: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the Tmax of MK-6194.
Apparent Clearance (CL/F) of MK-6194
Time frame: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the CL/F of MK-6194.
Apparent Terminal Half-life (t1/2) of MK-6194
Time frame: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the t1/2 of MK-6194.
Apparent Volume of Distribution (Vz/F) of MK-6194
Time frame: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the Vz/F of MK-6194.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event
Time frame: Up to approximately 12 weeks
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 12 weeks
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 21 Oct 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-6194 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 3 inclusion and 3 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 21 Oct 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 Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194 (time frame: At designated timepoints (up to approximately 4 weeks postdose)). 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 21 Oct 2024.