HealthyPhase 1NCT06609161
A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)
A Phase 1 study testing Tedizolid Phosphate Oral Formulation 1 (Reference) and Tedizolid Phosphate Oral Formulation 2 (Test) in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the oral formulations absorption and elimination from the healthy persons body. 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?
- Tedizolid Phosphate Oral Formulation 1 (Reference) and Tedizolid Phosphate Oral Formulation 2 (Test)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 8 Aug 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
- The key inclusion criteria include but are not limited to the following:
- Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a history of or presence of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), or uncorrected hypokalemia or hypomagnesemia
- Has a history of clostridium difficile-associated diarrhea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies
The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the oral formulations absorption and elimination from the healthy persons body.
- Conditions
- Healthy
- Being tested
- Tedizolid Phosphate Oral Formulation 1 (Reference), Tedizolid Phosphate Oral Formulation 2 (Test)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tedizolid Phosphate Oral Formulation 1 (Reference)Drug
Formulation 1 (FM1) powder for oral suspension.
Tedizolid Phosphate Oral Formulation 2 (Test)Drug
Formulation 2 (FM2) powder for oral suspension.
| Study group | Role | What they receive |
|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference) | Experimental | Participants will receive oral Formulation 1 (Reference). Receives: Drug: Tedizolid Phosphate Oral Formulation 1 (Reference) |
| Tedizolid Phosphate Oral Formulation 2 (Test) | Experimental | Participants will receive oral Formulation 2 (Test). Receives: Drug: Tedizolid Phosphate Oral Formulation 2 (Test) |
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 Infinity (AUC0-Inf) of Tedizolid
Blood samples will be collected to determine the AUC0-Inf of tedizolid.
Measured: At designated time points (up to 3 days postdose)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid
Blood samples will be collected to determine the AUC0-Last of tedizolid.
Measured: At designated time points (up to 3 days postdose)
Maximum Plasma Concentration (Cmax) of Tedizolid
Blood samples will be collected to determine the Cmax of tedizolid.
Measured: At designated time points (up to 3 days postdose)
Secondary outcomes (6)
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Measured: Up to approximately 2 weeks postdose
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Measured: Up to approximately 2 weeks postdose
Time to Maximum Plasma Concentration (Tmax) of Tedizolid
Blood samples will be collected to determine the Tmax of tedizolid.
Measured: At designated time points (up to 3 days postdose)
Apparent Terminal Half-Life (t1/2) of Tedizolid
Blood samples will be collected to determine the t1/2 of tedizolid.
Measured: At designated time points (up to 3 days postdose)
Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F)
Blood samples will be collected to determine the Vz/F of tedizolid.
Measured: At designated time points (up to 3 days postdose)
Apparent Clearance (CL/F) of Tedizolid
Blood samples will be collected to determine the CL/F of tedizolid.
Measured: At designated time points (up to 3 days postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start16 Jul 2024
- Primary completion8 Aug 2024
- Study completion8 Aug 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
- 18 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
- NCT06609161
- Sponsor's protocol ID
- 1986-044
- Other IDs
- MK-1986-044
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 27 Sep 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies
- ClinicalTrials.gov ID
- NCT06609161
- Acronym / sponsor ID
- 1986-044
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 24 Sep 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 the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the oral formulations absorption and elimination from the healthy persons body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference) | Experimental | Drug: Tedizolid Phosphate Oral Formulation 1 (Reference)Participants will receive oral Formulation 1 (Reference). |
| Tedizolid Phosphate Oral Formulation 2 (Test) | Experimental | Drug: Tedizolid Phosphate Oral Formulation 2 (Test)Participants will receive oral Formulation 2 (Test). |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
Key exclusion criteria (3 listed)
- Has a history of or presence of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), or uncorrected hypokalemia or hypomagnesemia
- Has a history of clostridium difficile-associated diarrhea
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 |
|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference)Formulation 1 (FM1) powder for oral suspension. | Drug | Tedizolid Phosphate Oral Formulation 1 (Reference) |
| Tedizolid Phosphate Oral Formulation 2 (Test)Formulation 2 (FM2) powder for oral suspension. | Drug | Tedizolid Phosphate Oral Formulation 2 (Test) |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid
Time frame: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the AUC0-Inf of tedizolid.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid
Time frame: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the AUC0-Last of tedizolid.
Maximum Plasma Concentration (Cmax) of Tedizolid
Time frame: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the Cmax of tedizolid.
6 secondary outcomes
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 2 weeks postdose
Number of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to approximately 2 weeks postdose
Time to Maximum Plasma Concentration (Tmax) of Tedizolid
Time frame: At designated time points (up to 3 days postdose)
Apparent Terminal Half-Life (t1/2) of Tedizolid
Time frame: At designated time points (up to 3 days postdose)
Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F)
Time frame: At designated time points (up to 3 days postdose)
Apparent Clearance (CL/F) of Tedizolid
Time frame: At designated time points (up to 3 days postdose)
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 27 Sep 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 Tedizolid Phosphate Oral Formulation 1 (Reference) and Tedizolid Phosphate Oral Formulation 2 (Test) 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 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 27 Sep 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 Infinity (AUC0-Inf) of Tedizolid (time frame: At designated time points (up to 3 days postdose)). The study lists 3 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 27 Sep 2024.