ObesityPhase 4NCT02342418
Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults
A Phase 4 study testing Tedizolid phosphate in people with Obesity, run by Amit.Pai.
Trial summary
This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal body weight- matched non-obese subjects. Qualifying subjects who have completed an informed consent will receive a single intravenous dose of tedizolid with the collection of 11 blood samples over 72 hours post dose. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Tedizolid phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers
- Estimated CLcr (Cockcroft-Gault equation) ≥ 90 mL/min
- Female subjects of childbearing potential (CBP) either surgically sterilized, using hormonal contraceptives or an effective barrier method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from the time of pre-study screening, during the entire study period and 4 weeks following the study period
- Platelets count ≥ 140,000/mL
- Absolute neutrophil count (ANC) ≥ 1800/mL
Who cannot join
- History of hypersensitivity reaction to any oxazolidinone
- BMI < 18.5 kg/m2
- Any chronic medical condition requiring pharmacologic therapy
- Transaminases (AST or ALT) > 2.5 x upper limit of normal
- Total bilirubin > 1.5 x upper limit of normal
- Positive urine pregnancy test (if female)
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- Abnormal electrocardiogram (ECG) as judged by the study physician
- Unable to tolerate venipuncture and multiple blood draws
- Clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up
- Unable to independently provide a written informed consent
About this study
Official title: Single Dose Pharmacokinetics of Intravenous Tedizolid Phosphate in Morbidly Obese and Age-, Sex-, and Ideal Body Weight-Matched Non-Obese Adults
This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal body weight- matched non-obese subjects. Qualifying subjects who have completed an informed consent will receive a single intravenous dose of tedizolid with the collection of 11 blood samples over 72 hours post dose.
Read the detailed description
Subjects will present to the clinical research unit in the morning (approximately 6:30 a.m.) of the dosing day. A urine pregnancy test will be performed to rule out pregnancy prior to administration of the tedizolid phosphate dose to female subjects. The subject's height, total body weight, and vital signs (heart rate, blood pressure, temperature, and respiratory rate) will be recorded. Subjects judged (by study physician) to be healthy enough to participate will proceed with the study procedures.
An 18-20 gauge intravenous peripheral catheter will be inserted into the antecubital vein or a vein in the fore-arm of the non-dominant arm for sequential blood sampling, and an initial predose blood sample (5 mL) will be collected. A minimum of 3-5 mL of blood is required per pharmacokinetic sampling time-point. Each blood collection tube will be pre-labeled with: 1.) study protocol number; 2.) subject study number; 3.) date of collection; 4.) time-point. A 0.9% Sodium Chloride infusion may be run through the peripheral line at 30 to 40 mL per hour to maintain catheter patency for the 12 hour sampling phase. Alternatively, a heparin lock technique will be utilized to maintain intravascular catheter patency.
A single-dose of tedizolid phosphate will be administered as an intravenous infusion (250 mL normal saline) over 1 hour (~8:00 a.m.). The intravenous administration tubing will be flushed with 0.9% Sodium Chloride infusion at 250 mL per hour (to match the tedizolid phosphate rate of infusion) for 10 minutes to ensure complete dose delivery. Blood samples (5 mL) will be collected 0.5 (middle of infusion), 1 (end of infusion), 2, 4, 6, 8, 12, 24, 48, and 72 hours post dose in blood collection tubes. The plasma will be harvested (centrifugation at 4°C) within 60 minutes of collection and stored at -70°C as two aliquots until analysis. The intravascular catheter "dead-space" volume will be discarded prior to blood sample collection by withdrawing 1.5-2 mL from the catheter to ensure no unintentional sample dilution. The intravascular catheter will be removed after the 12 hour sample and the subject will be discharged from the research unit. The subject will return to the research unit for blood sample collection on a daily basis at the following points: 24 (Visit 3), 48 (Visit 4), and 72 hours (Visit 5) after the dose via a peripheral vein needle stick. The exact date and time of blood sample collection will be recorded on case report forms. Each blood sample tube will be inverted and made up-right 5 times to afford mixing of blood with the anticoagulant. Blood samples will be maintained on wet ice and centrifuged at 1200 g for 10 minutes at 4°C within 60 minutes of collection to yield approximately 2 mL of plasma per 5 mL blood collection. The plasma samples will be transferred from the -20°C freezer for storage at -70°C at the end of the sample collection period until analysis.
- Conditions
- Obesity
- Being tested
- Tedizolid phosphate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tedizolid phosphateDrug
Also called Sivextro
Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
| Study group | Role | What they receive |
|---|---|---|
| Morbidly obese | Active comparator | The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter. Receives: Drug: Tedizolid phosphate |
| Non-obese | Active comparator | Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter. Receives: Drug: Tedizolid phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.
The area under the concentration-time curve is measured in units of mg of tedizolid per liter of plasma multiplied by time in hours (hour*mg/L) from time 0 to 72 hours. This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.
Measured: 12 months
Secondary outcomes (1)
This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects
The maximum concentration or Cmax value is measured in units of milligrams of tedizolid per liter of plasma.This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amit.Pai
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Amit.Pai, Albany College of Pharmacy and Health Sciences
- Investigators
- Manjunath Pai, PharmD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342418
- Sponsor's protocol ID
- 14-019
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2015
- Last updated
- 15 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Summative data have been published
Publications
Pai MP. Pharmacokinetics of Tedizolid in Morbidly Obese and Covariate-Matched Nonobese Adults. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4585-9. doi: 10.1128/AAC.00682-16. Print 2016 Aug.
PubMed 27185808
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Pharmacokinetics of Intravenous Tedizolid Phosphate in Morbidly Obese and Age-, Sex-, and Ideal Body Weight-Matched Non-Obese Adults
- ClinicalTrials.gov ID
- NCT02342418
- Acronym / sponsor ID
- 14-019
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Amit.PaiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal body weight- matched non-obese subjects. Qualifying subjects who have completed an informed consent will receive a single intravenous dose of tedizolid with the collection of 11 blood samples over 72 hours post dose.
Detailed description
Subjects will present to the clinical research unit in the morning (approximately 6:30 a.m.) of the dosing day. A urine pregnancy test will be performed to rule out pregnancy prior to administration of the tedizolid phosphate dose to female subjects. The subject's height, total body weight, and vital signs (heart rate, blood pressure, temperature, and respiratory rate) will be recorded. Subjects judged (by study physician) to be healthy enough to participate will proceed with the study procedures.
An 18-20 gauge intravenous peripheral catheter will be inserted into the antecubital vein or a vein in the fore-arm of the non-dominant arm for sequential blood sampling, and an initial predose blood sample (5 mL) will be collected. A minimum of 3-5 mL of blood is required per pharmacokinetic sampling time-point. Each blood collection tube will be pre-labeled with: 1.) study protocol number; 2.) subject study number; 3.) date of collection; 4.) time-point. A 0.9% Sodium Chloride infusion may be run through the peripheral line at 30 to 40 mL per hour to maintain catheter patency for the 12 hour sampling phase. Alternatively, a heparin lock technique will be utilized to maintain intravascular catheter patency.
A single-dose of tedizolid phosphate will be administered as an intravenous infusion (250 mL normal saline) over 1 hour (~8:00 a.m.). The intravenous administration tubing will be flushed with 0.9% Sodium Chloride infusion at 250 mL per hour (to match the tedizolid phosphate rate of infusion) for 10 minutes to ensure complete dose delivery. Blood samples (5 mL) will be collected 0.5 (middle of infusion), 1 (end of infusion), 2, 4, 6, 8, 12, 24, 48, and 72 hours post dose in blood collection tubes. The plasma will be harvested (centrifugation at 4°C) within 60 minutes of collection and stored at -70°C as two aliquots until analysis. The intravascular catheter "dead-space" volume will be discarded prior to blood sample collection by withdrawing 1.5-2 mL from the catheter to ensure no unintentional sample dilution. The intravascular catheter will be removed after the 12 hour sample and the subject will be discharged from the research unit. The subject will return to the research unit for blood sample collection on a daily basis at the following points: 24 (Visit 3), 48 (Visit 4), and 72 hours (Visit 5) after the dose via a peripheral vein needle stick. The exact date and time of blood sample collection will be recorded on case report forms. Each blood sample tube will be inverted and made up-right 5 times to afford mixing of blood with the anticoagulant. Blood samples will be maintained on wet ice and centrifuged at 1200 g for 10 minutes at 4°C within 60 minutes of collection to yield approximately 2 mL of plasma per 5 mL blood collection. The plasma samples will be transferred from the -20°C freezer for storage at -70°C at the end of the sample collection period until analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morbidly obese | Active comparator | Drug: Tedizolid phosphateThe morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter. |
| Non-obese | Active comparator | Drug: Tedizolid phosphateEach non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers
- Estimated CLcr (Cockcroft-Gault equation) ≥ 90 mL/min
- Female subjects of childbearing potential (CBP) either surgically sterilized, using hormonal contraceptives or an effective barrier method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from the time of pre-study screening, during the entire study period and 4 weeks following the study period
- Platelets count ≥ 140,000/mL
- Absolute neutrophil count (ANC) ≥ 1800/mL
Key exclusion criteria (10 listed)
- History of hypersensitivity reaction to any oxazolidinone
- BMI < 18.5 kg/m2
- Any chronic medical condition requiring pharmacologic therapy
- Transaminases (AST or ALT) > 2.5 x upper limit of normal
- Total bilirubin > 1.5 x upper limit of normal
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 |
|---|---|---|
| Tedizolid phosphateAlso: SivextroEach group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter. | Drug | Morbidly obese, Non-obese |
Primary outcome
This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.
Time frame: 12 months
The area under the concentration-time curve is measured in units of mg of tedizolid per liter of plasma multiplied by time in hours (hour*mg/L) from time 0 to 72 hours. This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.
1 secondary outcome
This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27185808Pai MP. Pharmacokinetics of Tedizolid in Morbidly Obese and Covariate-Matched Nonobese Adults. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4585-9. doi: 10.1128/AAC.00682-16. Print 2016 Aug.
- Individual participant dataSharing planned: No. Summative data have been published
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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.
Manjunath Pai, PharmD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tedizolid phosphate in people with Obesity, run by Amit.Pai.
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 5 inclusion and 10 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 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects. (time frame: 12 months). 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 NCT02342418, 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 15 Mar 2017.