Obesity
Conditions
Brief 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.
Detailed description
Not required
Interventions
DRUGTigecycline
100 mg IV as a single infusion over 30 minutes
Sponsors
Pfizer
Manjunath Prakash Pai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects fulfilling the following criteria will be eligible: 1. males and females, 18 to 50 years of age; 2. non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers; 3. Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III); 4. 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
Exclusion criteria
1. history of significant hypersensitivity reaction to any components of Tygacil®; 2. history of significant clinical illness requiring pharmacological management; 3. history of blood donation in the past eight week period; 4. abnormal serum electrolyte or complete blood count requiring further clinical work-up; 5. transaminases (AST or ALT) \> 2.5 x upper limit of normal; 6. subjects with stage 4 or 5 chronic kidney disease; 7. positive serum pregnancy test (if female); 8. abnormal electrocardiogram (ECG) as judged by study physician; 9. unable to tolerate venipuncture and multiple blood draws; 10. clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up; 11. unable to independently provide a written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tigecycline All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Tigecycline |
|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 10.5 |
| Body Mass Index | 43.8 kg/m^2 |
| Gender Female | 8 Participants |
| Gender Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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)
Time frame: 4 days (96 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serum AUC of Tigecycline | Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours | 7.64 hour*mg/L | Standard Deviation 1.28 |