Trial Outcomes & Findings for Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Subjects (NCT NCT02513446)
NCT ID: NCT02513446
Last Updated: 2019-03-29
Results Overview
Area under the concentration-time curve of BI 1026706 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
-3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration
Results posted on
2019-03-29
Participant Flow
An open-label, randomised, two-period, two-sequence crossover study with healthy male subjects
Participant milestones
| Measure |
Sequence RT
Treatment R (BI 1026706 alone):
Oral administration of a single dose of 25 mg BI 1026706 film-coated tablets was given on Day 1.
Treatment T (itraconazole + BI 1026706):
Itraconazole (200 mg) as capsules was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
The single dose administrations of BI 1026706 in treatments R and T were separated by a wash-out period of at least 10 days.
|
Sequence TR
Treatment T (itraconazole + BI 1026706):
Itraconazole (200 mg) as capsules was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
Treatment R (BI 1026706 alone):
Oral administration of a single dose of 25 mg BI 1026706 film-coated tablets was given on Day 1.
The single dose administrations of BI 1026706 in treatments T and R were separated by a wash-out period of at least 10 days.
|
|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
|
Period 1
COMPLETED
|
8
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 10 Days
STARTED
|
8
|
8
|
|
Washout Period of 10 Days
COMPLETED
|
8
|
8
|
|
Washout Period of 10 Days
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
8
|
8
|
|
Period 2
COMPLETED
|
8
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
Sequence RT
n=8 Participants
Treatment R (BI 1026706 alone):
Oral administration of a single dose of 25 mg BI 1026706 film-coated tablets was given on Day 1.
Treatment T (itraconazole + BI 1026706):
Itraconazole (200 mg) as capsules was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
The single dose administrations of BI 1026706 in treatments R and T were separated by a wash-out period of at least 10 days.
|
Sequence TR
n=8 Participants
Treatment T (itraconazole + BI 1026706):
Itraconazole (200 mg) as capsules was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
Treatment R (BI 1026706 alone):
Oral administration of a single dose of 25 mg BI 1026706 film-coated tablets was given on Day 1.
The single dose administrations of BI 1026706 in treatments T and R were separated by a wash-out period of at least 10 days.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
33.0 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
35.4 years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: -3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administrationPopulation: Pharmacokinetic set (PKS) included all treated subjects that provided at least 1 primary or secondary pharmacokinetic parameter that was not excluded due to a protocol violation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability..
Area under the concentration-time curve of BI 1026706 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Outcome measures
| Measure |
Treatment R (BI 1026706 Alone)
n=16 Participants
Oral administration of single dose of 25 mg BI 1026706 was given on Day 1.
|
Treatment T (Itraconazole + BI 1026706)
n=15 Participants
Itraconazole (200 mg) was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
|
|---|---|---|
|
Area Under the Curve of BI 1026706 From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
921 nmol*h/L
Geometric Coefficient of Variation 47.8
|
1580 nmol*h/L
Geometric Coefficient of Variation 55.9
|
PRIMARY outcome
Timeframe: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administrationPopulation: PKS
Maximum measured concentration of BI 1026706 in plasma (Cmax)
Outcome measures
| Measure |
Treatment R (BI 1026706 Alone)
n=16 Participants
Oral administration of single dose of 25 mg BI 1026706 was given on Day 1.
|
Treatment T (Itraconazole + BI 1026706)
n=15 Participants
Itraconazole (200 mg) was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
|
|---|---|---|
|
Maximum Concentration of BI 1026706 (Cmax)
|
206 nmol/L
Geometric Coefficient of Variation 48.9
|
279 nmol/L
Geometric Coefficient of Variation 62.2
|
SECONDARY outcome
Timeframe: -3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administrationPopulation: PKS
Area under the concentration-time curve of BI 1026706 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Outcome measures
| Measure |
Treatment R (BI 1026706 Alone)
n=16 Participants
Oral administration of single dose of 25 mg BI 1026706 was given on Day 1.
|
Treatment T (Itraconazole + BI 1026706)
n=15 Participants
Itraconazole (200 mg) was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
|
|---|---|---|
|
Area Under the Curve of BI 1026706 From 0 Extrapolated to Infinity (AUC0-inf)
|
943 nmol*h/L
Geometric Coefficient of Variation 46.9
|
1600 nmol*h/L
Geometric Coefficient of Variation 54.6
|
Adverse Events
Treatment R (BI 1026706 Alone)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment T (Itraconazole + BI 1026706)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment R (BI 1026706 Alone)
n=16 participants at risk
Oral administration of single dose of 25 mg BI 1026706 was given on Day 1.
|
Treatment T (Itraconazole + BI 1026706)
n=16 participants at risk
Itraconazole (200 mg) was given orally twice daily as a loading dose on Day -3 and once daily from Day -2 to Day 4 (7 days in total). A single dose of 25 mg BI 1026706 was given orally on the fourth day (Day 1) of the itraconazole treatment (1 h after the itraconazole administration on the respective day).
|
Total
n=16 participants at risk
Total
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
6.2%
1/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
12.5%
2/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
12.5%
2/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
12.5%
2/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
6.2%
1/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
6.2%
1/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
0.00%
0/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
6.2%
1/16 • From first drug administration through the residual effect period (REP) until the individual subject's end-of-trial; Up to 14 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place