HealthyPhase 1NCT06733688
A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)
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 absorption and elimination of different oral formulations from the healthy person's body. Read more about this study
- Who is it for?
- Ages 19 to 60 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
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 15 Apr 2022
- 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 60 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 before randomization
- Has a body mass index (BMI) ≥18.5 and ≤34 kg/m^2, inclusive
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 clinically significant cancer (malignancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Tedizolid Phosphate Single Unit Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Multiple Dose Bottle Powder for Oral Suspension
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 absorption and elimination of different oral formulations from the healthy person's 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
Also called MK-1986, TR-701 FA
Oral administration
Tedizolid Phosphate Oral Formulation 2 (Test)Drug
Also called MK-1986, TR-701 FA
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference) | Experimental | Participants receive tedizolid phosphate formulation 1 orally. Receives: Drug: Tedizolid Phosphate Oral Formulation 1 (Reference) |
| Tedizolid Phosphate Oral Formulation 2 (Test) | Experimental | Participants receive tedizolid phosphate formulation 2 orally. 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 the Last Measurable Concentration (AUC0-t) of Tedizolid
Blood samples will be collected to determine the AUC0-t 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)
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 After Nonintravenous Administration (Vd/F)
Blood samples will be collected to determine the Vd/F of tedizolid.
Measured: At designated time points (up to 3 days postdose)
Oral 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)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to approximately 2 weeks
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start23 Mar 2022
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
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
- 36 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
- NCT06733688
- Sponsor's protocol ID
- 1986-043
- Other IDs
- MK-1986-043
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 13 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 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Tedizolid Phosphate Single Unit Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Multiple Dose Bottle Powder for Oral Suspension
- ClinicalTrials.gov ID
- NCT06733688
- Acronym / sponsor ID
- 1986-043
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 13 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 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 absorption and elimination of different oral formulations from the healthy person's 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 receive tedizolid phosphate formulation 1 orally. |
| Tedizolid Phosphate Oral Formulation 2 (Test) | Experimental | Drug: Tedizolid Phosphate Oral Formulation 2 (Test)Participants receive tedizolid phosphate formulation 2 orally. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health before randomization
- Has a body mass index (BMI) ≥18.5 and ≤34 kg/m^2, inclusive
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 clinically significant 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 |
|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference)Also: MK-1986, TR-701 FAOral administration | Drug | Tedizolid Phosphate Oral Formulation 1 (Reference) |
| Tedizolid Phosphate Oral Formulation 2 (Test)Also: MK-1986, TR-701 FAOral administration | 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 the Last Measurable Concentration (AUC0-t) of Tedizolid
Time frame: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the AUC0-t 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
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 After Nonintravenous Administration (Vd/F)
Time frame: At designated time points (up to 3 days postdose)
Oral Clearance (CL/F) of Tedizolid
Time frame: At designated time points (up to 3 days postdose)
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 2 weeks
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 2 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 13 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 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 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 13 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 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 13 Dec 2024.