Trial Outcomes & Findings for Itraconazole Oral Absorption (NCT NCT04035187)
NCT ID: NCT04035187
Last Updated: 2023-10-05
Results Overview
area under the curve from 0-72hr
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
0-72hr
Results posted on
2023-10-05
Participant Flow
Recruitment was done through flyers and A/V advertisement throughout the University of Maryland Baltimore campus. Additionally, ResearchMatch.org was used. Planned initial interactions were phone calls and emails from potential subjects. Additionally, individuals who previously indicated a willingness to be contacted for future studies were contacted. Recruitment period was from September 17th 2019 to June 24th 2021.
Enrollment number is the number of participants who signed a consent form and passed screening tests.
Participant milestones
| Measure |
Sequence A (Fast, Medium, Oral Solution, Then Slow)
Participants first receive fast tablet, then medium tablet, then oral solution, and then slow tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence B (Medium, Slow, Fast, Then Oral Solution)
Participants first receive medium tablet, then slow tablet, then fast tablet, and then oral solution. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence C (Slow, Oral Solution, Medium, Then Fast)
Participants first receive slow tablet, then oral solution, then medium tablet, then fast tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence D (Oral Solution, Fast, Slow, Then Medium)
Participants first receive oral solution, fast tablet, then slow tablet, and then medium tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
5
|
|
Overall Study
COMPLETED
|
2
|
2
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence A (Fast, Medium, Oral Solution, Then Slow)
Participants first receive fast tablet, then medium tablet, then oral solution, and then slow tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence B (Medium, Slow, Fast, Then Oral Solution)
Participants first receive medium tablet, then slow tablet, then fast tablet, and then oral solution. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence C (Slow, Oral Solution, Medium, Then Fast)
Participants first receive slow tablet, then oral solution, then medium tablet, then fast tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence D (Oral Solution, Fast, Slow, Then Medium)
Participants first receive oral solution, fast tablet, then slow tablet, and then medium tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
|
Overall Study
Participant lived out of state and due to COVID-19 pandemic could not travel to study site.
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Itraconazole Oral Absorption
Baseline characteristics by cohort
| Measure |
Sequence A (Fast, Medium, Oral Solution, Then Slow)
n=4 Participants
Participants first receive fast tablet, then medium tablet, then oral solution, and then slow tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence B (Medium, Slow, Fast, Then Oral Solution)
n=4 Participants
Participants first receive medium tablet, then slow tablet, then fast tablet, and then oral solution. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence C (Slow, Oral Solution, Medium, Then Fast)
n=4 Participants
Participants first receive slow tablet, then oral solution, then medium tablet, then fast tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Sequence D (Oral Solution, Fast, Slow, Then Medium)
n=5 Participants
Participants first receive oral solution, fast tablet, then slow tablet, and then medium tablet. Washout period is (at least) one week.
fast itraconazole tablet: 100mg dose
medium itraconazole tablet: 100mg dose
slow itraconazole tablet: 100mg dose
oral itraconazole solution: 100mg dose
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 12 • n=7 Participants
|
28.3 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
41 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
34.5 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
17 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0-72hrPopulation: Seventeen participants were randomized in this cross-over study to receive all 4 itraconazole products at least one week apart. Twelve participants completed all 4 interventions. Analysis was only done of data from participants who completed all four interventions (n=12).
area under the curve from 0-72hr
Outcome measures
| Measure |
Fast Tablet
n=12 Participants
Fast-release itraconazole 100 mg tablet
|
Medium Tablet
n=12 Participants
Medium-release itraconazole 100 mg tablet
|
Slow Tablet
n=12 Participants
Slow-release itraconazole 100 mg tablet
|
Oral Solution
n=12 Participants
Oral solution itraconazole 100 mg
|
|---|---|---|---|---|
|
AUC
|
1624.8 ng*hr/mL
Standard Error 146.1
|
1365.5 ng*hr/mL
Standard Error 184
|
1282.2 ng*hr/mL
Standard Error 220.3
|
1848.7 ng*hr/mL
Standard Error 139.7
|
SECONDARY outcome
Timeframe: 0-72hrPopulation: Seventeen participants were randomized in this cross-over study to receive all 4 itraconazole products at least one week apart. Twelve participants completed all 4 interventions. Analysis was only done of data from participants who completed all four interventions.
maximum concentration during the time interval
Outcome measures
| Measure |
Fast Tablet
n=12 Participants
Fast-release itraconazole 100 mg tablet
|
Medium Tablet
n=12 Participants
Medium-release itraconazole 100 mg tablet
|
Slow Tablet
n=12 Participants
Slow-release itraconazole 100 mg tablet
|
Oral Solution
n=12 Participants
Oral solution itraconazole 100 mg
|
|---|---|---|---|---|
|
Cmax
|
174.3 ng/mL
Standard Error 30.9
|
108.5 ng/mL
Standard Error 14.9
|
121.3 ng/mL
Standard Error 26.4
|
266.7 ng/mL
Standard Error 40.5
|
Adverse Events
Fast Tablet
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medium Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Slow Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Oral Solution
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fast Tablet
n=14 participants at risk
All participants who received Fast-release itraconazole 100 mg tablet, regardless if they finish the cross-over study
|
Medium Tablet
n=14 participants at risk
All participants who received Medium-release itraconazole 100 mg tablet, regardless if they finish the cross-over study
|
Slow Tablet
n=13 participants at risk
All participants who received Slow-release itraconazole 100 mg tablet, regardless if they finish the cross-over study
|
Oral Solution
n=12 participants at risk
All participants who received Oral solution itraconazole 100 mg tablet, regardless if they finish the cross-over study
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
0.00%
0/14 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
0.00%
0/14 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
0.00%
0/13 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
0.00%
0/12 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
0.00%
0/13 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
0.00%
0/12 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/14 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
0.00%
0/14 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
0.00%
0/13 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from the time enrollment (signed consent) to the last study visit (72-hr blood draw time point).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place