ObesityPhase 4NCT01560143

Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

A Phase 4 study testing Tigecycline in people with Obesity, run by Manjunath Prakash Pai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

If tigecycline clearance increases with body size then serum exposure values will be lower in obese class III compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight. 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?: Tigecycline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Mar 2012to May 2012
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

Subjects fulfilling the following criteria will be eligible:
males and females, 18 to 50 years of age;
non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period

Who cannot join

history of significant hypersensitivity reaction to any components of Tygacil®;
history of significant clinical illness requiring pharmacological management;
history of blood donation in the past eight week period;
abnormal serum electrolyte or complete blood count requiring further clinical work-up;
transaminases (AST or ALT) > 2.5 x upper limit of normal;
subjects with stage 4 or 5 chronic kidney disease;

Show all 11Show fewer

positive serum pregnancy test (if female);
abnormal electrocardiogram (ECG) as judged by 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Albany College of Pharmacy
Albany, New York, 12186

Other trials in United States

About this study

Read the detailed description

Not required

Conditions: Obesity
Being tested: Tigecycline
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TigecyclineDrug
Also called Tygacil
100 mg IV as a single infusion over 30 minutes

Study groups in NCT01560143
Study group	Role	What they receive
Tigecycline	Other	All subjects receive a single dose of tigecycline Receives: Drug: Tigecycline

What is being measured

The primary outcome is the main question the study is designed to answer.

Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours
The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour*mg/L)
Measured: 4 days (96 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012May 2012

First posted22 Mar 2012 (estimated)
Study startMar 2012
Primary completionMay 2012
Study completionMay 2012

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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01560143
Sponsor's protocol ID: 11-007
Other IDs: WS2001231
Status last verified: Dec 2016
First submitted: 20 Mar 2012
Last updated: 9 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: The data have been published as a manuscript J Antimicrob Chemother. 2014 Jan;69(1):190-9.

Publications

Pai MP. Serum and urine pharmacokinetics of tigecycline in obese class III and normal weight adults. J Antimicrob Chemother. 2014 Jan;69(1):190-9. doi: 10.1093/jac/dkt299. Epub 2013 Jul 23.
PubMed 23883872

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
ClinicalTrials.gov ID: NCT01560143
Acronym / sponsor ID: 11-007
Conditions: Obesity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Manjunath Prakash PaiUniversity, hospital or other
Collaborators: Pfizer
Study start: Mar 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 22 Mar 2012 (estimated)
Results: Posted 6 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Not required

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tigecycline	Other	Drug: TigecyclineAll subjects receive a single dose of tigecycline

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

males and females, 18 to 50 years of age;
non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period

Key exclusion criteria (11 listed)

history of significant hypersensitivity reaction to any components of Tygacil®;
history of significant clinical illness requiring pharmacological management;
history of blood donation in the past eight week period;
abnormal serum electrolyte or complete blood count requiring further clinical work-up;
transaminases (AST or ALT) > 2.5 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
TigecyclineAlso: Tygacil100 mg IV as a single infusion over 30 minutes	Drug	Tigecycline

Primary outcome

Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours
Time frame: 4 days (96 hours)
The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour*mg/L)

Results and safety

Results posted to the registry on 6 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tigecycline	12	12

Primary outcome: Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours

Time frame: 4 days (96 hours). Mean (Standard Deviation). Unit: hour*mg/L

Measure	Serum AUC of Tigecycline n = 12
Value	7.64 (1.28)

Adverse events

Time frame: 4 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tigecycline	0 of 12 (0%)	3 of 12 (25%)	Not reported

Limitations and caveats (from the sponsor): Small study sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23883872Pai MP. Serum and urine pharmacokinetics of tigecycline in obese class III and normal weight adults. J Antimicrob Chemother. 2014 Jan;69(1):190-9. doi: 10.1093/jac/dkt299. Epub 2013 Jul 23.
Individual participant dataSharing planned: No. The data have been published as a manuscript J Antimicrob Chemother. 2014 Jan;69(1):190-9.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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 P Pai, PharmD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tigecycline in people with Obesity, run by Manjunath Prakash Pai 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 5 inclusion and 11 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 9 Feb 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 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 6 Dec 2016). 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?

Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours (time frame: 4 days (96 hours)). 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 NCT01560143, 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 9 Feb 2017.