Trial Outcomes & Findings for A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood (NCT NCT04257032)
NCT ID: NCT04257032
Last Updated: 2024-02-23
Results Overview
Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration.
COMPLETED
PHASE1
28 participants
Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.
2024-02-23
Participant Flow
An open, single-dose, randomised, two-period, two way crossover design in each trial part to evaluate the relative bioavailability of rosuvastatin (Part 1) and dabigatran (Part 2) given alone and together with BI 1323495 in healthy male subjects.
All participants were entered/randomized for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all inclusion and none of the exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
Part 1: Rosuvastatin (R1) / Rosuvastatin + BI 1323495 (T1)
In part 1 (Reference (R1)- Test (T1)), on trial day 1 of period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 1 (R1). Period 1 is followed by a washout period of at least 7 days. In part 1, on trial day 1 of period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test treatment 1 (T1).
|
Part 1: Rosuvastatin + BI 1323495 (T1) / Rosuvastatin (R1)
In part 1 (Test (T1)- Reference (R1)), on trial day 1 of period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 milliliter (mL) of water after a standardised breakfast as test treatment 1 (T1). Period 1 is followed by a washout period of at least 7 days. In part 1, on trial day 1 of period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was administered with 240 mL of water after a standardised breakfast as reference treatment 1 (R1).
|
Part 2: Dabigatran (R2) / Dabigatran + BI 1323495 (T2)
In part 2 (Reference (R2)- Test 2 (T2)), on trial day 1 of period 1, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 2 (R2). Period 1 is followed by a washout period of at least 7 days. In part 2, on trial day 1 of period 2, a single oral dose of 1 hard capsule of 75 mg dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test treatment 2 (T2).
|
Part 2: Dabigatran + BI 1323495 (T2) / Dabigatran (R2)
In part 2 (Test 2 (T2) - Reference (R2)), on trial day 1 of period 1, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 milliliter (mL) of water after a standardised breakfast as test treatment 2 (T2). Period 1 is followed by a washout period of at least 7 days. In part 2, on trial day 1 of period 2, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 2 (R2).
|
|---|---|---|---|---|
|
Period 1 (+ Washout Period)
STARTED
|
7
|
7
|
7
|
7
|
|
Period 1 (+ Washout Period)
COMPLETED
|
7
|
7
|
7
|
7
|
|
Period 1 (+ Washout Period)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
7
|
7
|
7
|
7
|
|
Period 2
COMPLETED
|
7
|
7
|
7
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood
Baseline characteristics by cohort
| Measure |
Part 1: Rosuvastatin (R1) / Rosuvastatin + BI 1323495 (T1)
n=7 Participants
In part 1 (Reference (R1)- Test (T1)), on trial day 1 of period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 1 (R1). Period 1 is followed by a washout period of at least 7 days. In part 1, on trial day 1 of period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test treatment 1 (T1).
|
Part 1: Rosuvastatin + BI 1323495 (T1) / Rosuvastatin (R1)
n=7 Participants
In part 1 (Test (T1)- Reference (R1)), on trial day 1 of period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 milliliter (mL) of water after a standardised breakfast as test treatment 1 (T1). Period 1 is followed by a washout period of at least 7 days. In part 1, on trial day 1 of period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was administered with 240 mL of water after a standardised breakfast as reference treatment 1 (R1).
|
Part 2: Dabigatran (R2) / Dabigatran + BI 1323495 (T2)
n=7 Participants
In part 2 (Reference (R2)- Test 2 (T2)), on trial day 1 of period 1, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 2 (R2). Period 1 is followed by a washout period of at least 7 days. In part 2, on trial day 1 of period 2, a single oral dose of 1 hard capsule of 75 mg dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test treatment 2 (T2).
|
Part 2: Dabigatran + BI 1323495 (T2) / Dabigatran (R2)
n=7 Participants
In part 2 (Test 2 (T2) - Reference (R2)), on trial day 1 of period 1, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 milliliter (mL) of water after a standardised breakfast as test treatment 2 (T2). Period 1 is followed by a washout period of at least 7 days. In part 2, on trial day 1 of period 2, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 2 (R2).
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.4 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
44.3 Years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
36.6 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
35.7 Years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
39.3 Years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 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
|
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)
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
|
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)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 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
|
PRIMARY outcome
Timeframe: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.Population: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS:All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Rosuvastatin:AUC0-∞ only calculated for 12 subjects, due for 2 subjects concentrations at last sampling point were higher than at preceding time point.
Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration.
Outcome measures
| Measure |
Rosuvastatin (Part 1, Reference 1)
n=12 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1).
|
Rosuvastatin + BI 1323495 (Part 1, Test 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1).
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
23.92 Hours * nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.13
|
25.20 Hours * nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.12
|
PRIMARY outcome
Timeframe: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.Population: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of the analyte (rosuvastatin) in plasma (Cmax). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration.
Outcome measures
| Measure |
Rosuvastatin (Part 1, Reference 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1).
|
Rosuvastatin + BI 1323495 (Part 1, Test 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1).
|
|---|---|---|
|
Part 1: Maximum Measured Concentration of the Analyte (Rosuvastatin) in Plasma (Cmax)
|
2.20 Nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.14
|
2.52 Nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.14
|
PRIMARY outcome
Timeframe: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.Population: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Outcome measures
| Measure |
Rosuvastatin (Part 1, Reference 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1).
|
Rosuvastatin + BI 1323495 (Part 1, Test 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1).
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
666.24 Hours * nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.08
|
720.76 Hours * nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.08
|
PRIMARY outcome
Timeframe: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.Population: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of the analyte (dabigatran) in plasma (Cmax) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Outcome measures
| Measure |
Rosuvastatin (Part 1, Reference 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1).
|
Rosuvastatin + BI 1323495 (Part 1, Test 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1).
|
|---|---|---|
|
Part 2: Maximum Measured Concentration of the Analyte (Dabigatran) in Plasma (Cmax)
|
80.01 Nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.08
|
87.12 Nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.08
|
SECONDARY outcome
Timeframe: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.Population: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration.
Outcome measures
| Measure |
Rosuvastatin (Part 1, Reference 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1).
|
Rosuvastatin + BI 1323495 (Part 1, Test 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1).
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
21.50 Hours * nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.14
|
22.47 Hours * nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.14
|
SECONDARY outcome
Timeframe: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.Population: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Outcome measures
| Measure |
Rosuvastatin (Part 1, Reference 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1).
|
Rosuvastatin + BI 1323495 (Part 1, Test 1)
n=14 Participants
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1).
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
647.05 Hours * nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.08
|
701.55 Hours * nanogramm / milliliter
Standard Error NA
(Adjusted) Geometric Standard Error = 1.08
|
Adverse Events
Rosuvastatin (Part 1, Reference 1)
Rosuvastatin + BI 1323495 (Part 1, Test 1)
Dabigatran (Part 2, Reference 2)
Dabigatran + BI 1323495 (Part 2, Test 2)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rosuvastatin (Part 1, Reference 1)
n=14 participants at risk
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1).
|
Rosuvastatin + BI 1323495 (Part 1, Test 1)
n=14 participants at risk
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1).
|
Dabigatran (Part 2, Reference 2)
n=14 participants at risk
In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 2 (R2).
|
Dabigatran + BI 1323495 (Part 2, Test 2)
n=14 participants at risk
In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 2 (T2).
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
7.1%
1/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
7.1%
1/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Disturbance in attention
|
7.1%
1/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
28.6%
4/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/14 • From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place