Hepatic ImpairmentPhase 1NCT01431833
A PK and Safety Study in Subjects With Hepatic Impairment
A Phase 1 study testing TR-701 FA in people with Hepatic Impairment, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 2 sites in United States.
Trial summary
Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- 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
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate or severe hepatic impairment or matched control
- BMI between 18.0 and 40.0 kg/m2
Who cannot join
- Evidence of acute deterioration of hepatic function within 8 weeks
- ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes
- Total bilirubin > 5 mg/dl for moderates; no upper limit for severes
- Hemoglobin < 10g/dl for moderates; Hemoglobin < 9g/dl for severes
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 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment
Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.
Read the detailed description
This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- TR-701 FA
- Keywords
- Hepatic Impairment, Matched control subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-701 FADrug
Oral single dose 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Moderate hepatic | Experimental | Not described Receives: Drug: TR-701 FA |
| Severe Hepatic | 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.
PK Assessment
PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance.
Measured: 7 days
Secondary outcomes (1)
Safety
Safety Assessments evaluated through adverse events, laboratory evaluations (hematology and chemistry), vital signs, ECGs, and physical examinations, in moderate and severe hepatic impairment and matched controls.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startAug 2011
- 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 Hepatic 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- Phillippe G Prokocimer, MD, Study chair, Trius Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431833
- Sponsor's protocol ID
- 1986-001
- Other IDs
- TR701-124
- Status last verified
- May 2016
- First submitted
- 5 Aug 2011
- Last updated
- 20 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 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT01431833
- Acronym / sponsor ID
- 1986-001
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment, Matched control subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Sep 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.
Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.
Detailed description
This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate hepatic | Experimental | Drug: TR-701 FA |
| Severe Hepatic | Experimental | Drug: TR-701 FA |
| Matched control | Experimental | Drug: TR-701 FA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate or severe hepatic impairment or matched control
- BMI between 18.0 and 40.0 kg/m2
Key exclusion criteria (4 listed)
- Evidence of acute deterioration of hepatic function within 8 weeks
- ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes
- Total bilirubin > 5 mg/dl for moderates; no upper limit for severes
- Hemoglobin < 10g/dl for moderates; Hemoglobin < 9g/dl for severes
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 FAOral single dose 200 mg | Drug | Matched control, Moderate hepatic, Severe Hepatic |
Primary outcome
PK Assessment
Time frame: 7 days
PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance.
1 secondary outcome
Safety
Time frame: 7 days
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 20 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.
Phillippe G 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 in people with Hepatic 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 2 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 20 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?
PK Assessment (time frame: 7 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 NCT01431833, 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 20 May 2016.