Healthy VolunteerPhase 1NCT01461460
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
A Phase 1 study testing TR-701 FA 1200 mg and Moxifloxacin 400 mg in people with Healthy Volunteer, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- TR-701 FA 1200 mg and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2011to 23 Dec 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 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.
- Body mass index ≥18.0 kg/m2 and ≤30.0 kg/m2
Who cannot join
- Sustained supine systolic blood pressure >140 or <100 mmHg or a diastolic blood pressure >90 or <60 mmHg at the Screening and Day 1 Visit.
- Abnormal ECG at Screening or Day -1 Visits indicating a second or third-degree atrioventricular block, or QRS >110 msec, QTcF >450 msec for males and >470 msec for females, PR interval >200 msec, or any rhythm other than sinus rhythm which is interpreted by the Investigator as clinically significant - History of unexplained infections or current signs of infection
- History of risk factors for Torsades de Pointes, including unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, hypomagnesemia, or family history of Long QT Syndrome or Brugada Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
Read the detailed description
To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.
- Conditions
- Healthy Volunteer
- Being tested
- TR-701 FA 1200 mg, Moxifloxacin 400 mg, TR-701 FA 200 mg plus Placebo, Placebo
- Keywords
- volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-701 FA 1200 mgDrug
Also called Tedizolid
6 tablet of T-701 FA
Moxifloxacin 400 mgDrug
1 tablet 400 mg Moxifloxacin
TR-701 FA 200 mg plus PlaceboDrug
Also called Tedizolid
1 tablet of TR-701 FA with 5 tablet placebo
PlaceboDrug
6 placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin 400 mg | Active comparator | Not described Receives: Drug: Moxifloxacin 400 mg |
| TR-701 FA 1200 mg | Experimental | Not described Receives: Drug: TR-701 FA 1200 mg |
| TR-701 FA 200 mg plus Placebo | Experimental | Not described Receives: Drug: TR-701 FA 200 mg plus Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTcF Change from Baseline
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study start28 Nov 2011
- Primary completion23 Dec 2011
- Study completion23 Dec 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 Healthy VolunteerStudies 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, Care provider
- Enrolment
- 48 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
- NCT01461460
- Sponsor's protocol ID
- 1986-029
- Other IDs
- TR701-115
- Status last verified
- Dec 2018
- First submitted
- 26 Oct 2011
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Flanagan S, Litwin J, Fang E, Prokocimer P. Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study. Int J Antimicrob Agents. 2016 Jul;48(1):33-40. doi: 10.1016/j.ijantimicag.2015.12.015. Epub 2016 Jun 2.
PubMed 27342387
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
- ClinicalTrials.gov ID
- NCT01461460
- Acronym / sponsor ID
- 1986-029
- Conditions
- Healthy Volunteer
- Keywords
- volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2011 (actual)
- Primary completion
- 23 Dec 2011 (actual)
- Study completion
- 23 Dec 2011 (actual)
- First posted
- 28 Oct 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 purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
Detailed description
To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin 400 mg | Active comparator | Drug: Moxifloxacin 400 mg |
| TR-701 FA 1200 mg | Experimental | Drug: TR-701 FA 1200 mg |
| TR-701 FA 200 mg plus Placebo | Experimental | Drug: TR-701 FA 200 mg plus Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
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.
- Body mass index ≥18.0 kg/m2 and ≤30.0 kg/m2
Key exclusion criteria (3 listed)
- Sustained supine systolic blood pressure >140 or <100 mmHg or a diastolic blood pressure >90 or <60 mmHg at the Screening and Day 1 Visit.
- Abnormal ECG at Screening or Day -1 Visits indicating a second or third-degree atrioventricular block, or QRS >110 msec, QTcF >450 msec for males and >470 msec for females, PR interval >200 msec, or any rhythm other than sinus rhythm which is interpreted by the Investigator as clinically significant - History of unexplained infections or current signs of infection
- History of risk factors for Torsades de Pointes, including unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, hypomagnesemia, or family history of Long QT Syndrome or Brugada Syndrome
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 1200 mgAlso: Tedizolid6 tablet of T-701 FA | Drug | TR-701 FA 1200 mg |
| Moxifloxacin 400 mg1 tablet 400 mg Moxifloxacin | Drug | Moxifloxacin 400 mg |
| TR-701 FA 200 mg plus PlaceboAlso: Tedizolid1 tablet of TR-701 FA with 5 tablet placebo | Drug | TR-701 FA 200 mg plus Placebo |
| Placebo6 placebo tablets | Drug | Placebo |
Primary outcome
QTcF Change from Baseline
Time frame: 24 Hours
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
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 5 Dec 2018.
- Background: PubMed 27342387Flanagan S, Litwin J, Fang E, Prokocimer P. Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study. Int J Antimicrob Agents. 2016 Jul;48(1):33-40. doi: 10.1016/j.ijantimicag.2015.12.015. Epub 2016 Jun 2.
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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 1200 mg and Moxifloxacin 400 mg in people with Healthy Volunteer, 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 5 Dec 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?
QTcF Change from Baseline (time frame: 24 Hours). 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 NCT01461460, 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 5 Dec 2018.