Trial Outcomes & Findings for Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations (NCT NCT01307930)
NCT ID: NCT01307930
Last Updated: 2019-01-09
Results Overview
How quickly the body eliminates anidulafungin after a single dose
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
0-72 hours
Results posted on
2019-01-09
Participant Flow
Participant milestones
| Measure |
Anidulafungin
The study will have 18 participants complete the 72 hour sampling period. 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.
Anidulafungin: Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)
|
|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations
Baseline characteristics by cohort
| Measure |
Anidulafungin
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.
Anidulafungin: Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0-72 hoursPopulation: Noncompartmental analysis of anidulafungin clearance
How quickly the body eliminates anidulafungin after a single dose
Outcome measures
| Measure |
Anidulafungin
n=18 Participants
Single dose of 100 mg by IV infusion.
|
|---|---|
|
Serum Clearance of Anidulafungin
|
0.94 L/hr
Interval 0.72 to 1.93
|
Adverse Events
Anidulafungin
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 |
Anidulafungin
n=20 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.
Anidulafungin: Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)
|
|---|---|
|
Immune system disorders
Rash
|
10.0%
2/20 • Number of events 2 • 3 days
Adverse events were collected upon report of the participant to study staff.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place