Healthy SubjectsPhase 1NCT01577459
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response
A Phase 1 study testing TR-701 FA with PSE in people with Healthy Subjects, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TR-701 FA with PSE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2012to 15 Jun 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 and 45 years of age, inclusive
- Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
- Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2
Who cannot join
- Systolic blood pressure > 130 mmHg or < 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
- Diastolic blood pressure > 90 mmHg or < 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
- Heart rate > 90 bpm or < 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
- Known allergy or hypersensitivity to PSE
Trial locations and contacts
1 site in 1 country.
United States1 site
Trius Investigator Site 001
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA
This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.
Read the detailed description
Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.
- Conditions
- Healthy Subjects
- Being tested
- TR-701 FA with PSE, TR-701 FA Placebo with PSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-701 FA with PSEDrug
Also called Tedizolid Phosphate
TR-701 FA Oral 200 mg oral with PSE
TR-701 FA Placebo with PSEOther
TR-701 FA Placebo Oral 200 mg with PSE
| Study group | Role | What they receive |
|---|---|---|
| TR-701 FA with PSE | Experimental | TR-701 FA 200 mg oral with PSE Receives: Drug: TR-701 FA with PSE |
| TR-701 FA Placebo with PSE | Placebo comparator | TR-701 FA Placebo 200 mg oral with PSE Receives: Other: TR-701 FA Placebo with PSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study start23 Apr 2012
- Primary completion15 Jun 2012
- Study completion15 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- NCT01577459
- Sponsor's protocol ID
- 1986-033
- Other IDs
- TR701-114
- Status last verified
- Aug 2018
- First submitted
- 11 Apr 2012
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Flanagan S, Minassian SL, Prokocimer P. Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers. J Clin Med. 2018 Jun 14;7(6):150. doi: 10.3390/jcm7060150.
PubMed 29899212Flanagan 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 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA
- ClinicalTrials.gov ID
- NCT01577459
- Acronym / sponsor ID
- 1986-033
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2012 (actual)
- Primary completion
- 15 Jun 2012 (actual)
- Study completion
- 15 Jun 2012 (actual)
- First posted
- 13 Apr 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.
This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.
Detailed description
Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR-701 FA with PSE | Experimental | Drug: TR-701 FA with PSETR-701 FA 200 mg oral with PSE |
| TR-701 FA Placebo with PSE | Placebo comparator | Other: TR-701 FA Placebo with PSETR-701 FA Placebo 200 mg oral with PSE |
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 and 45 years of age, inclusive
- Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
- Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2
Key exclusion criteria (4 listed)
- Systolic blood pressure > 130 mmHg or < 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
- Diastolic blood pressure > 90 mmHg or < 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
- Heart rate > 90 bpm or < 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
- Known allergy or hypersensitivity to PSE
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 PSEAlso: Tedizolid PhosphateTR-701 FA Oral 200 mg oral with PSE | Drug | TR-701 FA with PSE |
| TR-701 FA Placebo with PSETR-701 FA Placebo Oral 200 mg with PSE | Other | TR-701 FA Placebo with PSE |
Primary outcome
Systolic Blood Pressure
Time frame: 13 days
To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo
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 Aug 2018.
- Results publication: PubMed 29899212Flanagan S, Minassian SL, Prokocimer P. Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers. J Clin Med. 2018 Jun 14;7(6):150. doi: 10.3390/jcm7060150.
- 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 PSE in people with Healthy Subjects, 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 4 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 Aug 2018. 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: 13 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 NCT01577459, which also lists 2 linked publications.
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 Aug 2018.