Trial Outcomes & Findings for A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1323495 in the Blood (NCT NCT04011241)
NCT ID: NCT04011241
Last Updated: 2024-02-22
Results Overview
Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Within 3 hours (h) prior and 0.33, 0.67, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 47, 71, 95 (period 1) and additional 119, 143, 167h (period 2) after administration.
Results posted on
2024-02-22
Participant Flow
This is an open-label, two-treatment, two-period, one-way fixed-sequence design to investigate the relative bioavailability of a single oral dose of BI 1323495 when given alone (Period 1) as reference treatment (R) or in combination with itraconazole (Period 2) as test treatment (T) in healthy male subjects.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 1323495 (R) / BI 1323495 + Itraconazole (T)
A single oral dose of 10 milligrams (mg) BI 1323495, film-coated tablet, was administered once on day 1, period 1, visit 2, as reference treatment R, followed by a washout period of at least 7 days, followed by period 2, visit 3, in which a single oral dose of 200 mg itraconazole (oral solution, 20 milliliter (mL) per day with 10 mg/mL) was administered once daily from day -3 to day 7, in total 10 doses. On day 1 of visit 3, 4th day of itraconazole treatment, a single oral dose of 10 mg BI 132345 was administered 1 hour (h) after itraconazole administration as test treatment T.
BI 1323495 and itraconazole were orally administered with 240 mL of water after an overnight fast of at least 10 h for BI 1323495 and 9 h for itraconazole.
|
|---|---|
|
Treatment Period 1
STARTED
|
14
|
|
Treatment Period 1
COMPLETED
|
14
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
|
Washout Period
STARTED
|
14
|
|
Washout Period
COMPLETED
|
14
|
|
Washout Period
NOT COMPLETED
|
0
|
|
Treatment Period 2
STARTED
|
14
|
|
Treatment Period 2
COMPLETED
|
14
|
|
Treatment 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 1323495 in the Blood
Baseline characteristics by cohort
| Measure |
BI 1323495 (R) / BI 1323495 + Itraconazole (T)
n=14 Participants
A single oral dose of 10 milligrams (mg) BI 1323495, film-coated tablet, was administered once on day 1, period 1, visit 2, as reference treatment R, followed by a washout period of at least 7 days, followed by period 2, visit 3, in which a single oral dose of 200 mg itraconazole (oral solution, 20 milliliter (mL) per day with 10 mg/mL) was administered once daily from day -3 to day 7, in total 10 doses. On day 1 of visit 3, 4th day of itraconazole treatment, a single oral dose of 10 mg BI 132345 was administered 1 hour (h) after itraconazole administration as test treatment T.
BI 1323495 and itraconazole were orally administered with 240 mL of water after an overnight fast of at least 10 h for BI 1323495 and 9 h for itraconazole.
|
|---|---|
|
Age, Continuous
|
38.9 Years
STANDARD_DEVIATION 7.8 • 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: Within 3 hours (h) prior and 0.33, 0.67, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 47, 71, 95 (period 1) and additional 119, 143, 167h (period 2) after administration.Population: Pharmacokintetic parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability.
Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Outcome measures
| Measure |
BI 1323495 (R)
n=14 Participants
Single oral dose of 10 milligrams (mg) of film-coated tablet of BI 1323495 was administered once on day 1 in the first treatment period (period 1, visit 2) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment R.
|
BI 1323495 + Itraconazole (T)
n=14 Participants
Single oral dose of 200 mg itraconazole (oral solution, 20 milliliter (mL) per day with 10 mg/mL) was administered once daily with 240 mL of water after an overnight fast of 9 hours (h) from day -3 to day 7 (total: 10 doses) in the second treatment period (period 2, visit 3) together with a single oral dose of 10 mg BI 1323495 administered 1 h after itraconazole administration with 240 mL of water after an overnight fast of 10 h on the fourth day of the itraconazole treatment (day 1, period 2, visit 3) as test treatment T.
|
|---|---|---|
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Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
124.15 Nanomoles * hour per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.29
|
215.66 Nanomoles * hour per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.29
|
PRIMARY outcome
Timeframe: Within 3 hours (h) prior and 0.33, 0.67, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 47, 71, 95 (period 1) and additional 119, 143, 167h (period 2) after administration.Population: Pharmacokintetic parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability.
Maximum measured concentration of BI 1323495 in plasma (Cmax)
Outcome measures
| Measure |
BI 1323495 (R)
n=14 Participants
Single oral dose of 10 milligrams (mg) of film-coated tablet of BI 1323495 was administered once on day 1 in the first treatment period (period 1, visit 2) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment R.
|
BI 1323495 + Itraconazole (T)
n=14 Participants
Single oral dose of 200 mg itraconazole (oral solution, 20 milliliter (mL) per day with 10 mg/mL) was administered once daily with 240 mL of water after an overnight fast of 9 hours (h) from day -3 to day 7 (total: 10 doses) in the second treatment period (period 2, visit 3) together with a single oral dose of 10 mg BI 1323495 administered 1 h after itraconazole administration with 240 mL of water after an overnight fast of 10 h on the fourth day of the itraconazole treatment (day 1, period 2, visit 3) as test treatment T.
|
|---|---|---|
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Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)
|
10.49 Nanomoles per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.23
|
14.41 Nanomoles per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.23
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior and 0.33, 0.67, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 47, 71, 95 (period 1) and additional 119, 143, 167h (period 2) after administration.Population: Pharmacokintetic parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability.
Area under the concentration-time cure of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Outcome measures
| Measure |
BI 1323495 (R)
n=13 Participants
Single oral dose of 10 milligrams (mg) of film-coated tablet of BI 1323495 was administered once on day 1 in the first treatment period (period 1, visit 2) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment R.
|
BI 1323495 + Itraconazole (T)
n=10 Participants
Single oral dose of 200 mg itraconazole (oral solution, 20 milliliter (mL) per day with 10 mg/mL) was administered once daily with 240 mL of water after an overnight fast of 9 hours (h) from day -3 to day 7 (total: 10 doses) in the second treatment period (period 2, visit 3) together with a single oral dose of 10 mg BI 1323495 administered 1 h after itraconazole administration with 240 mL of water after an overnight fast of 10 h on the fourth day of the itraconazole treatment (day 1, period 2, visit 3) as test treatment T.
|
|---|---|---|
|
Area Under the Concentration-time Cure of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
178.29 Nanomoles * hour per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.24
|
300.66 Nanomoles * hour per Liter
Standard Error NA
Adjusted Geometric Standard Error = 1.25
|
Adverse Events
BI 1323495
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Itraconazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1323495 + Itraconazole
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 |
BI 1323495
n=14 participants at risk
Single oral dose of 10 milligrams (mg) of film-coated tablet of BI 1323495 was administered once on day 1 in the first treatment period (period 1, visit2) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment R.
|
Itraconazole
n=14 participants at risk
Single oral dose of 200 mg itraconazole (oral solution, 20 milliliter (mL) per day with 10 mg/mL) was administered once daily with 240 mL of water after an overnight fast of 9 hours (h) from day -3 to day -1 (total: 3 doses) in the second treatment period (period 2, visit 3) as test treatment T.
|
BI 1323495 + Itraconazole
n=14 participants at risk
Single oral dose of 200 mg itraconazole (oral solution, 20 milliliter (mL) per day with 10 mg/mL) was administered once daily with 240 mL of water after an overnight fast of 9 hours (h) from day 1 to day 7 (total: 7 doses) in the second treatment period (period 2, visit 3) together with a single oral dose of 10 mg BI 1323495 administered 1 h after itraconazole administration with 240 mL of water after an overnight fast of 10 h on the fourth day of the itraconazole treatment (day 1, period 2, visit 3) as test treatment T.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
14.3%
2/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
14.3%
2/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Gastrointestinal infection
|
7.1%
1/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • BI 1323495 (BI): 1st BI administration (AD) up to 7 days (D) thereafter; Itraconazole (IT): 1st IT until 2nd AD of BI or last IT AD up to 9D if discontinuation prior to 2nd BI AD; BI + IT: 2nd BI AD up to 7D or last IT AD up to 9D, whichever was later.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
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