Trial Outcomes & Findings for A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 730357 in the Blood (NCT NCT03782987)
NCT ID: NCT03782987
Last Updated: 2023-07-12
Results Overview
AUC0-tz, area under the concentration-time curve of the BI 730357 in plasma over the time interval from 0 to the last quantifiable data point is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.
Results posted on
2023-07-12
Participant Flow
This was an open-label, two-treatment, two-period, one-way crossover trial in healthy participants in order to compare the test treatment (T) to the reference treatment (R). All participants underwent treatment R in Period 1 (Visit 2) and treatment T in Period 2 (Visit 3). There was at least 10 days washout between the administrations of BI 730357.
All participants were screened for eligibility to participate in the trial. Participants attended specialist site which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be entered to trial if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
BI 730357 Alone/ BI 730357+Itraconazole
Participants were administered 50 milligram (mg) BI 730357 tablet orally on Day 1 alone in treatment period 1 (R) and along with 20 milliliter (mL) of 10 mg/ mL Itraconazole oral solution on Day 1 of treatment period 2 (T). Itraconazole was administered once daily on Day -3, -2, -1 and 1 before administration of BI 730357 and on Day 2 to 9 in treatment period 2 only. There was a washout interval of at least 10 days between the administrations of BI 730357.
|
|---|---|
|
Period 1
STARTED
|
14
|
|
Period 1
COMPLETED
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
|
Washout Period
STARTED
|
14
|
|
Washout Period
COMPLETED
|
14
|
|
Washout Period
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
14
|
|
Period 2
COMPLETED
|
14
|
|
Period 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 730357 in the Blood
Baseline characteristics by cohort
| Measure |
BI 730357 Alone/ BI 730357+Itraconazole
n=14 Participants
Participants were administered 50 milligram (mg) BI 730357 tablet orally on Day 1 alone in treatment period 1 (R) and along with 20 milliliter (mL) of 10 mg/ mL Itraconazole oral solution on Day 1 of treatment period 2 (T). Itraconazole was administered once daily on Day -3, -2, -1 and 1 before administration of BI 730357 and on Day 2 to 9 in treatment period 2 only. There was a washout interval of at least 10 days between the administrations of BI 730357.
|
|---|---|
|
Age, Continuous
|
37.8 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.Population: Pharmacokinetic (PK) parameter set (PKS): The PKS included all subjects of the TS who provided at least 1 primary or secondary PK parameter that was not excluded due to relevant protocol deviations or due to PK non-evaluability.
AUC0-tz, area under the concentration-time curve of the BI 730357 in plasma over the time interval from 0 to the last quantifiable data point is presented.
Outcome measures
| Measure |
BI 730357 + Itraconazole (T)
n=14 Participants
Participants were administered 50 mg BI 730357 tablet orally on Day 1 along with 20 mL of 10 mg/ mL Itraconazole oral solution in treatment period 2 only (T). Itraconazole was administered once daily for 12 days from Day -3 to Day 9.
|
BI 730357 (R)
n=14 Participants
Participants were administered 50 mg BI 730357 tablet orally on Day 1 alone in treatment period 1 (R).
|
|---|---|---|
|
Area Under the Concentration-time Curve of the BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
43239.08 Nanomole* hour/ Litre (nmol*h/ L)
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.09
|
6657.49 Nanomole* hour/ Litre (nmol*h/ L)
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.09
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.Population: PKS
Cmax, maximum measured concentration of the BI 730357 in plasma is presented here.
Outcome measures
| Measure |
BI 730357 + Itraconazole (T)
n=14 Participants
Participants were administered 50 mg BI 730357 tablet orally on Day 1 along with 20 mL of 10 mg/ mL Itraconazole oral solution in treatment period 2 only (T). Itraconazole was administered once daily for 12 days from Day -3 to Day 9.
|
BI 730357 (R)
n=14 Participants
Participants were administered 50 mg BI 730357 tablet orally on Day 1 alone in treatment period 1 (R).
|
|---|---|---|
|
Maximum Measured Concentration of the BI 730357 in Plasma (Cmax)
|
311.01 nmol/ L
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.07
|
186.36 nmol/ L
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.07
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.Population: PKS
AUC0-∞, area under the concentration-time curve of the BI 730357 in plasma over the time interval from 0 extrapolated to infinity is presented here.
Outcome measures
| Measure |
BI 730357 + Itraconazole (T)
n=14 Participants
Participants were administered 50 mg BI 730357 tablet orally on Day 1 along with 20 mL of 10 mg/ mL Itraconazole oral solution in treatment period 2 only (T). Itraconazole was administered once daily for 12 days from Day -3 to Day 9.
|
BI 730357 (R)
n=14 Participants
Participants were administered 50 mg BI 730357 tablet orally on Day 1 alone in treatment period 1 (R).
|
|---|---|---|
|
Area Under the Concentration-time Curve of the BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
64934.55 nmol*h/ L
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.10
|
6971.67 nmol*h/ L
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.10
|
Adverse Events
BI 730357 (R)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Itraconazole
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 730357 + Itraconazole (T)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 730357 (R)
n=14 participants at risk
Participants were administered 50 mg BI 730357 tablet orally on Day 1 alone in treatment period 1 (R).
|
Itraconazole
n=14 participants at risk
Participants were administered Itraconazole oral solution once daily on Day -3 to Day 1 before administration of 50 mg BI 730357 and on Day 2 to 9 after administration of BI 730357 in treatment period 2 only (T).
|
BI 730357 + Itraconazole (T)
n=14 participants at risk
Participants were administered 50 mg BI 730357 tablet orally on Day 1 along with 20 mL of 10 mg/ mL Itraconazole oral solution in treatment period 2 only (T). Itraconazole was administered once daily for 12 days from Day -3 to Day 9.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
14.3%
2/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
14.3%
2/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
14.3%
2/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
21.4%
3/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
7.1%
1/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
0.00%
0/14 • BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days.
Treated set (TS): The TS included all subjects who received at least 1 dose of trial medication.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place