Bacterial InfectionPhase 1NCT01271998
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg
A Phase 1 study testing TR-701 FA in people with Bacterial Infection, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- TR-701 FA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2010to 3 Jan 2011
- 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
- Healthy males and females, between 18 and 55 years of age, inclusive
- Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
- Males must be surgically sterile, abstinent, or practicing an effective method of birth control
- BMI between 20 and 34.9 kg/m2, inclusive
Who cannot join
- Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
- Physician-diagnosed migraine headaches within 3 years
- Previous enrollment in a TR-701 or TR-701 FA trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Trius Investigator Site 001
Hartford, Connecticut, 06102
About this study
Official title: Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers
The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.
Read the detailed description
No applicable.
- Conditions
- Bacterial Infection
- Being tested
- TR-701 FA
- Keywords
- antibiotic, healthy subjects, pharmacokinetics
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-701 FADrug
200 mg, oral, once daily for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteer | Experimental | healthy volunteers Receives: Drug: TR-701 FA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters from plasma.
Pharmacokinetic parameters compared with baseline measurements.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study start8 Dec 2010
- Primary completion3 Jan 2011
- Study completion3 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Nicolau, PharmD, Principal investigator, Center for Anti-Infective Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271998
- Sponsor's protocol ID
- 1986-027
- Other IDs
- TR701-119
- Status last verified
- Nov 2019
- First submitted
- 7 Dec 2010
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Housman ST, Pope JS, Russomanno J, Salerno E, Shore E, Kuti JL, Nicolau DP. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother. 2012 May;56(5):2627-34. doi: 10.1128/AAC.05354-11. Epub 2012 Feb 13.
PubMed 22330925
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01271998
- Acronym / sponsor ID
- 1986-027
- Conditions
- Bacterial Infection
- Keywords
- antibiotic, healthy subjects, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2010 (actual)
- Primary completion
- 3 Jan 2011 (actual)
- Study completion
- 3 Jan 2011 (actual)
- First posted
- 7 Jan 2011 (estimated)
- 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 primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.
Detailed description
No applicable.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteer | Experimental | Drug: TR-701 FAhealthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males and females, between 18 and 55 years of age, inclusive
- Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
- Males must be surgically sterile, abstinent, or practicing an effective method of birth control
- BMI between 20 and 34.9 kg/m2, inclusive
Key exclusion criteria (3 listed)
- Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
- Physician-diagnosed migraine headaches within 3 years
- Previous enrollment in a TR-701 or TR-701 FA trial
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 |
|---|---|---|
| TR-701 FA200 mg, oral, once daily for 3 days. | Drug | healthy volunteer |
Primary outcome
Pharmacokinetic parameters from plasma.
Time frame: Day 3
Pharmacokinetic parameters compared with baseline measurements.
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 15 Nov 2019.
- Results publication: PubMed 22330925Housman ST, Pope JS, Russomanno J, Salerno E, Shore E, Kuti JL, Nicolau DP. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother. 2012 May;56(5):2627-34. doi: 10.1128/AAC.05354-11. Epub 2012 Feb 13.
- 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.
David Nicolau, PharmD principal investigator
Center for Anti-Infective Research and Development
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 TR-701 FA in people with Bacterial Infection, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) 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 4 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 15 Nov 2019. 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?
Pharmacokinetic parameters from plasma. (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271998, which also lists 1 linked publication.
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 15 Nov 2019.