Trial Outcomes & Findings for Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects (NCT NCT01560143)
NCT ID: NCT01560143
Last Updated: 2017-02-09
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
4 days (96 hours)
Results posted on
2017-02-09
Participant Flow
Participant milestones
| Measure |
Tigecycline
All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Baseline characteristics by cohort
| Measure |
Tigecycline
n=12 Participants
All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes
|
|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
|
Gender
Female
|
8 Participants
n=99 Participants
|
|
Gender
Male
|
4 Participants
n=99 Participants
|
|
Body Mass Index
|
43.8 kg/m^2
n=99 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Serum AUC of Tigecycline
n=12 Participants
All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes
|
|---|---|
|
Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours
|
7.64 hour*mg/L
Standard Deviation 1.28
|
Adverse Events
Tigecycline
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tigecycline
n=12 participants at risk
All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • 4 days
|
|
Gastrointestinal disorders
Emesis
|
8.3%
1/12 • Number of events 1 • 4 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place