Trial Outcomes & Findings for Effect of Weight and/or Obesity on Caspofungin Drug Concentrations (NCT NCT01062165)
NCT ID: NCT01062165
Last Updated: 2017-02-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)
Results posted on
2017-02-10
Participant Flow
Volunteers recruited with fliers at medical center.
Participant milestones
| Measure |
Capsofungin
Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Weight and/or Obesity on Caspofungin Drug Concentrations
Baseline characteristics by cohort
| Measure |
Capsofungin
n=18 Participants
Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
|
Gender
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)Outcome measures
| Measure |
Capsofungin
n=18 Participants
Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
|
|---|---|
|
Total Clearance of Caspofungin
|
0.508 L/hr
Standard Deviation 0.223
|
Adverse Events
Capsofungin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Capsofungin
n=18 participants at risk
Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
|
|---|---|
|
General disorders
Headache
|
5.6%
1/18 • Number of events 1 • 72 hours
|
|
General disorders
Hot flashes and sweating
|
5.6%
1/18 • Number of events 1 • 72 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place