Healthy SubjectsPhase 1NCT01496677
Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects
A Phase 1 study testing TR-701 FA 200 mg 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
To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TR-701 FA 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2012to 28 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects in the following groups: An elderly subject at least 65 years of age. At least 5 subjects must be at least 75 years of age OR A matched-control subject between 18 and 45 years of age, inclusive
- BMI ≥18.0 kg/m2 and ≤35.0 kg/m2
- Elderly Group
- Medical history, physical examination, and laboratory results consistent with stable health (as determined by the Investigator)
- Control Group
- Medically stable with no clinically significant abnormalities
Who cannot join
- Significant, uncontrolled, or life-threatening condition or organ or system condition or disease (eg, impaired cognitive status, respiratory insufficiency, advanced malnutrition)
- Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result
- Previous inclusion in a TR-701 FA or TR-701 clinical study
- ECG finding of QTc interval >500 msec, or other clinically significant ECG abnormality at Screening
- Female subjects whom are pregnant, lactating or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Trius Investigator Site 001
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1 Open-Label Study With Oral TR-701 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects
To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects
Read the detailed description
This is an open-label Phase 1 study of a single oral tablet of TR-701 FA 200 mg to compare the TR-700 PK profile in elderly subjects (age 65 years and older, with at least 5 subjects 75 years old or older) and younger control subjects (age 18 to 45 years).
- Conditions
- Healthy Subjects
- Being tested
- TR-701 FA 200 mg
- Keywords
- volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-701 FA 200 mgDrug
Single oral tablet of TR-701 FA to elderly subjects
TR-701 FA 200 mgDrug
Single oral tablet of TR-701 FA to younger group (18-45 years old)
| Study group | Role | What they receive |
|---|---|---|
| Elderly subjects (65 or older) | Experimental | Not described Receives: Drug: TR-701 FA 200 mg |
| Younger adults (18-45 years old) | Experimental | Not described Receives: Drug: TR-701 FA 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study start17 Jan 2012
- Primary completion28 Feb 2012
- Study completion28 Feb 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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT01496677
- Sponsor's protocol ID
- 1986-028
- Other IDs
- TR701-109
- Status last verified
- Oct 2017
- First submitted
- 19 Dec 2011
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Flanagan SD, Minassian SL, Prokocimer P. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate in Elderly Subjects. Clin Pharmacol Drug Dev. 2018 Sep;7(7):788-794. doi: 10.1002/cpdd.426. Epub 2018 Jan 10.
PubMed 29319932
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. 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 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects
- ClinicalTrials.gov ID
- NCT01496677
- Acronym / sponsor ID
- 1986-028
- Conditions
- Healthy Subjects
- Keywords
- volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2012 (actual)
- Primary completion
- 28 Feb 2012 (actual)
- Study completion
- 28 Feb 2012 (actual)
- First posted
- 21 Dec 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.
To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects
Detailed description
This is an open-label Phase 1 study of a single oral tablet of TR-701 FA 200 mg to compare the TR-700 PK profile in elderly subjects (age 65 years and older, with at least 5 subjects 75 years old or older) and younger control subjects (age 18 to 45 years).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly subjects (65 or older) | Experimental | Drug: TR-701 FA 200 mg |
| Younger adults (18-45 years old) | Experimental | Drug: TR-701 FA 200 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects in the following groups: An elderly subject at least 65 years of age. At least 5 subjects must be at least 75 years of age OR A matched-control subject between 18 and 45 years of age, inclusive
- BMI ≥18.0 kg/m2 and ≤35.0 kg/m2
- Elderly Group
- Medical history, physical examination, and laboratory results consistent with stable health (as determined by the Investigator)
- Control Group
Key exclusion criteria (5 listed)
- Significant, uncontrolled, or life-threatening condition or organ or system condition or disease (eg, impaired cognitive status, respiratory insufficiency, advanced malnutrition)
- Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result
- Previous inclusion in a TR-701 FA or TR-701 clinical study
- ECG finding of QTc interval >500 msec, or other clinically significant ECG abnormality at Screening
- Female subjects whom are pregnant, lactating or breastfeeding
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 200 mgSingle oral tablet of TR-701 FA to elderly subjects | Drug | Elderly subjects (65 or older) |
| TR-701 FA 200 mgSingle oral tablet of TR-701 FA to younger group (18-45 years old) | Drug | Younger adults (18-45 years old) |
Primary outcome
Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects
Time frame: 28 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 6 Oct 2017.
- Derived from this study: PubMed 29319932Flanagan SD, Minassian SL, Prokocimer P. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate in Elderly Subjects. Clin Pharmacol Drug Dev. 2018 Sep;7(7):788-794. doi: 10.1002/cpdd.426. Epub 2018 Jan 10.
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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 200 mg 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 6 inclusion and 5 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 6 Oct 2017. 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. 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?
Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects (time frame: 28 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 NCT01496677, 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 6 Oct 2017.