Healthy VolunteersPhase 1NCT01539473
A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge
A Phase 1 study testing TR-701 FA with Tyramine in people with Healthy Volunteers, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TR-701 FA with Tyramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects between 18 to 45 years of age, inclusive
- Body mass index between 19 kg/m2 and 31 kg/m2, inclusive
- Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,
Who cannot join
- Systolic blood pressure >130 mmHg or <90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center
- Heart rate >90 bpm or <45 bpm measured after 10 minutes in the supine position
- Electrocardiogram (ECG) finding of QTc interval >500 msec, or other clinically significant ECG abnormality at the Screening Visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Trius Investigator Site 001
Evansville, Indiana, 47710
About this study
Official title: A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge
Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- TR-701 FA with Tyramine, Placebo-controlled withTyramine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-701 FA with TyramineDrug
Also called Tedizolid Phosphate
TR-701 FA 200 mg oral and Tyramine
Placebo-controlled withTyramineDrug
Placebo-controlled and Tyramine
| Study group | Role | What they receive |
|---|---|---|
| TR-701 FA with Tyramine | Experimental | TR-701 FA 200 oral with Tyramine Receives: Drug: TR-701 FA with Tyramine |
| Placebo-controlled with Tyramine | Placebo comparator | Placebo-controlled with Tyramine Receives: Drug: Placebo-controlled withTyramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
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 Healthy VolunteersStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- Philippe G Prokocimer, MD, Study chair, Trius Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539473
- Sponsor's protocol ID
- 1986-032
- Other IDs
- TR701-105
- Status last verified
- May 2016
- First submitted
- 21 Feb 2012
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.
PubMed 23612197
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge
- ClinicalTrials.gov ID
- NCT01539473
- Acronym / sponsor ID
- 1986-032
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 Feb 2012 (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.
Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR-701 FA with Tyramine | Experimental | Drug: TR-701 FA with TyramineTR-701 FA 200 oral with Tyramine |
| Placebo-controlled with Tyramine | Placebo comparator | Drug: Placebo-controlled withTyraminePlacebo-controlled with Tyramine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female subjects between 18 to 45 years of age, inclusive
- Body mass index between 19 kg/m2 and 31 kg/m2, inclusive
- Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,
Key exclusion criteria (3 listed)
- Systolic blood pressure >130 mmHg or <90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center
- Heart rate >90 bpm or <45 bpm measured after 10 minutes in the supine position
- Electrocardiogram (ECG) finding of QTc interval >500 msec, or other clinically significant ECG abnormality at the Screening Visit
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 FA with TyramineAlso: Tedizolid PhosphateTR-701 FA 200 mg oral and Tyramine | Drug | TR-701 FA with Tyramine |
| Placebo-controlled withTyraminePlacebo-controlled and Tyramine | Drug | Placebo-controlled with Tyramine |
Primary outcome
Systolic Blood Pressure
Time frame: 14 days
To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure
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 3 May 2016.
- Derived from this study: PubMed 23612197Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.
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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.
Philippe G Prokocimer, MD study chair
Trius Therapeutics
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 with Tyramine in people with Healthy Volunteers, 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 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 3 May 2016. 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. Some participants in this study may receive a placebo. 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?
Systolic Blood Pressure (time frame: 14 days). 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 NCT01539473, 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 3 May 2016.