HealthyPhase 1NCT02753855
Pharmacokinetics of Telavancin in Normal and Obese Subjects
A Phase 1 study testing Telavancin in people with Healthy, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this study is to characterize plasma and urinary concentrations of telavancin following intravenous administration of a single dose of telavancin in healthy subjects who are normal weight, overweight, and obese. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects, 18 to 50 years
- Nonsmokers within the last 1 year
- Weight > 110 lbs
Who cannot join
- History of significant hypersensitivity reaction or intolerance to telavancin
- Aspartate or alanine aminotransferase > 1.5 times the upper limit of normal
- Estimated creatinine clearance <60 mL/minute and serum creatinine >1.5 mg/dL
- Female subjects who are pregnant or breast feeding
- History of alcohol or substance abuse or dependence within the last 1 year
- Use of prescription or nonprescription drugs (unless hormonal contraceptives) within 7 to 14 days prior to telavancin administration
- Participation in a clinical trials within last 30 days
- Donated blood (>500 mL) within the last 56 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
The purpose of this study is to characterize plasma and urinary concentrations of telavancin following intravenous administration of a single dose of telavancin in healthy subjects who are normal weight, overweight, and obese.
Read the detailed description
This study is a Phase I, open-label, single-dose pharmacokinetic study in healthy adult male and female subjects. Eligible subjects will be assigned to one of four groups based on their body mass index and total body weight. Subjects will receive a single dose of telavancin depending on subject's group as a 1-hour intravenous infusion. Serial blood and urine samples will be collected over 12 hours to determine serum and urinary pharmacokinetics of telavancin. Subjects will return for blood and urine sample collection at 24 and 48 hours. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests, monitoring of adverse events, and markers of kidney injury.
- Conditions
- Healthy
- Being tested
- Telavancin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelavancinDrug
Also called Vibativ
A single dose of telavancin as a 1-hour intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Telavancin Administration | Experimental | Single dose of telavancin administered as a 1-hour intravenous infusion Receives: Drug: Telavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (%) of adverse events of any severity regardless of relationship to study drug
Measured: 48 hours
Area-under-the-plasma concentration-time curve (AUC0-infinity)
To estimate the telavancin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC0-infinity) after a single dose of telavancin in healthy adult participants
Measured: 48 hours
Maximum plasma concentration (Cmax)
To estimate the telavancin pharmacokinetic parameter maximum plasma concentration (Cmax) after a single dose for intravenously dosed telavancin to healthy adult participants
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
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 HealthyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Theravance Biopharma
- Responsible party
- Principal investigator, Keith A. Rodvold, University of Illinois Chicago
- Investigators
- Keith A. Rodvold, Pharm.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753855
- Sponsor's protocol ID
- TELAPK-2015
- Status last verified
- Nov 2016
- First submitted
- 18 Apr 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bunnell KL, Pai MP, Sikka M, Bleasdale SC, Wenzler E, Danziger LH, Rodvold KA. Pharmacokinetics of Telavancin at Fixed Doses in Normal-Body-Weight and Obese (Classes I, II, and III) Adult Subjects. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02475-17. doi: 10.1128/AAC.02475-17. Print 2018 Apr.
PubMed 29311094
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Telavancin in Normal and Obese Subjects
- ClinicalTrials.gov ID
- NCT02753855
- Acronym / sponsor ID
- TELAPK-2015
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Theravance Biopharma
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Apr 2016 (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 characterize plasma and urinary concentrations of telavancin following intravenous administration of a single dose of telavancin in healthy subjects who are normal weight, overweight, and obese.
Detailed description
This study is a Phase I, open-label, single-dose pharmacokinetic study in healthy adult male and female subjects. Eligible subjects will be assigned to one of four groups based on their body mass index and total body weight. Subjects will receive a single dose of telavancin depending on subject's group as a 1-hour intravenous infusion. Serial blood and urine samples will be collected over 12 hours to determine serum and urinary pharmacokinetics of telavancin. Subjects will return for blood and urine sample collection at 24 and 48 hours. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests, monitoring of adverse events, and markers of kidney injury.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telavancin Administration | Experimental | Drug: TelavancinSingle dose of telavancin administered as a 1-hour intravenous infusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult subjects, 18 to 50 years
- Nonsmokers within the last 1 year
- Weight > 110 lbs
Key exclusion criteria (8 listed)
- History of significant hypersensitivity reaction or intolerance to telavancin
- Aspartate or alanine aminotransferase > 1.5 times the upper limit of normal
- Estimated creatinine clearance <60 mL/minute and serum creatinine >1.5 mg/dL
- Female subjects who are pregnant or breast feeding
- History of alcohol or substance abuse or dependence within the last 1 year
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 |
|---|---|---|
| TelavancinAlso: VibativA single dose of telavancin as a 1-hour intravenous infusion | Drug | Telavancin Administration |
Primary outcome
Number (%) of adverse events of any severity regardless of relationship to study drug
Time frame: 48 hours
Area-under-the-plasma concentration-time curve (AUC0-infinity)
Time frame: 48 hours
To estimate the telavancin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC0-infinity) after a single dose of telavancin in healthy adult participants
Maximum plasma concentration (Cmax)
Time frame: 48 hours
To estimate the telavancin pharmacokinetic parameter maximum plasma concentration (Cmax) after a single dose for intravenously dosed telavancin to healthy adult participants
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 2 Nov 2016.
- Derived from this study: PubMed 29311094Bunnell KL, Pai MP, Sikka M, Bleasdale SC, Wenzler E, Danziger LH, Rodvold KA. Pharmacokinetics of Telavancin at Fixed Doses in Normal-Body-Weight and Obese (Classes I, II, and III) Adult Subjects. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02475-17. doi: 10.1128/AAC.02475-17. Print 2018 Apr.
- Individual participant dataSharing planned: No
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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.
Keith A. Rodvold, Pharm.D. principal investigator
University of Illinois Chicago
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 Telavancin in people with Healthy, run by University of Illinois Chicago 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 8 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 2 Nov 2016. 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?
Number (%) of adverse events of any severity regardless of relationship to study drug (time frame: 48 hours). The study lists 3 primary outcomes in all. 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 NCT02753855, 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 2 Nov 2016.