Renal ImpairmentPhase 1NCT01452828
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
A Phase 1 study testing TR-701 FA single infusion and TR-701 FA in people with Renal Impairment, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 2 sites in United States.
Trial summary
The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Impairment
- What is being tested?
- TR-701 FA single infusion and TR-701 FA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 18.0 and 40.0 kg/m2 inclusive
- Male or female subjects between 18 and 75 years of age
- Stable dosage of medication for 30 days
- for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months
Who cannot join
- Functioning transplanted solid organ
- High tyramine diet
- Significant, unstable, or life-threatening condition or organ or system condition or disease, other than kidney disease in renal subjects
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Trius Investigator Site 002
Minneapolis, Minnesota, 55404
Trius Investigator Site 001
Orlando, Florida, 32809
About this study
Official title: A Phase I Open-Label Study With 200 mg Intravenous TR-701 Free Acid to Assess Safety and Pharmacokinetics in Advanced Renal Impairment Subjects
The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.
Read the detailed description
To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with normal renal function
- Conditions
- Renal Impairment
- Being tested
- TR-701 FA single infusion, TR-701 FA
- Keywords
- Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-701 FA single infusionDrug
Also called Tedizolid
Single IV infusion, 200 mg daily for 7 days
TR-701 FADrug
Also called Tedizolid
Two separate infusions of 200 mg
TR-701 FADrug
Also called Tedizolid
Single IV infusion, 200 mg daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Renal Impairment Nondialyzed | Experimental | Not described Receives: Drug: TR-701 FA single infusion |
| Renal Impairment Dialyzed | Experimental | Not described Receives: Drug: TR-701 FA |
| Matched Control | Experimental | Not described Receives: Drug: TR-701 FA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite (or Profile) of Pharmacokinetics
Cmax, Area Under Curve, Tmax t1/2 will be compared between each renal group and the control group, including calculation of geometric mean ratio and corresponding 90% confidence intervals.
Measured: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 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 Renal ImpairmentStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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 Prokocimer, MD, Study chair, Trius Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452828
- Sponsor's protocol ID
- 1986-031
- Other IDs
- TR701-123
- Status last verified
- May 2016
- First submitted
- 21 Sep 2011
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18.
PubMed 25136024
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 I Open-Label Study With 200 mg Intravenous TR-701 Free Acid to Assess Safety and Pharmacokinetics in Advanced Renal Impairment Subjects
- ClinicalTrials.gov ID
- NCT01452828
- Acronym / sponsor ID
- 1986-031
- Conditions
- Renal Impairment
- Keywords
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 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 single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.
Detailed description
To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with normal renal function
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Renal Impairment Nondialyzed | Experimental | Drug: TR-701 FA single infusion |
| Renal Impairment Dialyzed | Experimental | Drug: TR-701 FA |
| Matched Control | Experimental | Drug: TR-701 FA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 18.0 and 40.0 kg/m2 inclusive
- Male or female subjects between 18 and 75 years of age
- Stable dosage of medication for 30 days
- for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months
Key exclusion criteria (3 listed)
- Functioning transplanted solid organ
- High tyramine diet
- Significant, unstable, or life-threatening condition or organ or system condition or disease, other than kidney disease in renal subjects
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 single infusionAlso: TedizolidSingle IV infusion, 200 mg daily for 7 days | Drug | Renal Impairment Nondialyzed |
| TR-701 FAAlso: TedizolidTwo separate infusions of 200 mg | Drug | Renal Impairment Dialyzed |
| TR-701 FAAlso: TedizolidSingle IV infusion, 200 mg daily for 7 days | Drug | Matched Control |
Primary outcome
Composite (or Profile) of Pharmacokinetics
Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 hours post-dose
Cmax, Area Under Curve, Tmax t1/2 will be compared between each renal group and the control group, including calculation of geometric mean ratio and corresponding 90% confidence intervals.
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 25136024Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18.
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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 Prokocimer, MD study chair
Trius Therapeutics
2 sites 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 single infusion and TR-701 FA in people with Renal Impairment, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 2 sites 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 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 2 sites 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?
Composite (or Profile) of Pharmacokinetics (time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 hours post-dose). 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 NCT01452828, 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.