Trial Outcomes & Findings for A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body (NCT NCT04232839)
NCT ID: NCT04232839
Last Updated: 2024-09-19
Results Overview
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.
Results posted on
2024-09-19
Participant Flow
Formulation selection and subsequent optimization of two different oral formulations of BI 894416 in healthy male subjects (open-label, randomised, single-dose study in two parts; trial part 1: five-period crossover design with an additional sixth period in a fixed sequence; (optional) trial part 2: three-period crossover followed by a two-period crossover design), trial part 2 was not performed.
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 |
T3-R1-T1-T4-T2-T5 (Sequence I+T5)
Sequence I+T5, with treatments in the following order: T3-R1-T1-T4-T2-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
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T3-R1-T1-T4-T2-T6 (Sequence I+T6)
Sequence I+T6, with treatments in the following order: T3-R1-T1-T4-T2-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
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T2-T1-T3-R1-T4-T5 (Sequence II+T5)
Sequence II+T5, with treatments in the following order: T2-T1-T3-R1-T4-T5with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
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T2-T1-T3-R1-T4-T6 (Sequence II+T6)
Sequence II+T6, with treatments in the following order: T2-T1-T3-R1-T4-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
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T4-T3-R1-T2-T1-T5 (Sequence III+T5)
Sequence III+T5, with treatments in the following order: T4-T3-R1-T2-T1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
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T4-T3-R1-T2-T1-T6 (Sequence III+T6)
Sequence III+T6, with treatments in the following order: T4-T3-R1-T2-T1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
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T1-T4-T2-T3-R1-T5 (Sequence IV+T5)
Sequence IV+T5, with treatments in the following order: T1-T4-T2-T3-R1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
T1-T4-T2-T3-R1-T6 (Sequence IV+T6)
Sequence IV+T6, with treatments in the following order: T1-T4-T2-T3-R1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
R1-T2-T4-T1-T3-T5 (Sequence V+T5)
Sequence V+T5, with treatments in the following order: R1-T2-T4-T1-T3-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
R1-T2-T4-T1-T3-T6 (Sequence V+T6)
Sequence V+T6, with treatments in the following order: R1-T2-T4-T1-T3-T6with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
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Treatment Period 1 + Washout
STARTED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 1 + Washout
COMPLETED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 1 + Washout
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period 2 + Washout
STARTED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 2 + Washout
COMPLETED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 2 + Washout
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period 3 + Washout
STARTED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 3 + Washout
COMPLETED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 3 + Washout
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period 4 + Washout
STARTED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 4 + Washout
COMPLETED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 4 + Washout
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period 5 + Washout
STARTED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 5 + Washout
COMPLETED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 5 + Washout
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period 6
STARTED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 6
COMPLETED
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2
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2
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2
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3
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2
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2
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3
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3
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2
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3
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Treatment Period 6
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body
Baseline characteristics by cohort
| Measure |
T3-R1-T1-T4-T2-T5 (Sequence I+T5)
n=2 Participants
Sequence I+T5, with treatments in the following order: T3-R1-T1-T4-T2-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
T3-R1-T1-T4-T2-T6 (Sequence I+T6)
n=2 Participants
Sequence I+T6, with treatments in the following order: T3-R1-T1-T4-T2-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
T2-T1-T3-R1-T4-T5 (Sequence II+T5)
n=2 Participants
Sequence II+T5, with treatments in the following order: T2-T1-T3-R1-T4-T5with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
T2-T1-T3-R1-T4-T6 (Sequence II+T6)
n=3 Participants
Sequence II+T6, with treatments in the following order: T2-T1-T3-R1-T4-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
T4-T3-R1-T2-T1-T5 (Sequence III+T5)
n=2 Participants
Sequence III+T5, with treatments in the following order: T4-T3-R1-T2-T1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
T4-T3-R1-T2-T1-T6 (Sequence III+T6)
n=2 Participants
Sequence III+T6, with treatments in the following order: T4-T3-R1-T2-T1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
T1-T4-T2-T3-R1-T5 (Sequence IV+T5)
n=3 Participants
Sequence IV+T5, with treatments in the following order: T1-T4-T2-T3-R1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
T1-T4-T2-T3-R1-T6 (Sequence IV+T6)
n=3 Participants
Sequence IV+T6, with treatments in the following order: T1-T4-T2-T3-R1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
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R1-T2-T4-T1-T3-T5 (Sequence V+T5)
n=2 Participants
Sequence V+T5, with treatments in the following order: R1-T2-T4-T1-T3-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
R1-T2-T4-T1-T3-T6 (Sequence V+T6)
n=3 Participants
Sequence V+T6, with treatments in the following order: R1-T2-T4-T1-T3-T6with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast.
Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets.
Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR).
Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR).
Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 17.7 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
29.5 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
39.0 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
31.5 years
STANDARD_DEVIATION 2.1 • n=10 Participants
|
30.0 years
STANDARD_DEVIATION 8.2 • n=115 Participants
|
43.3 years
STANDARD_DEVIATION 13.2 • n=24 Participants
|
25.0 years
STANDARD_DEVIATION 4.2 • n=42 Participants
|
25.3 years
STANDARD_DEVIATION 5.9 • n=42 Participants
|
32.6 years
STANDARD_DEVIATION 9.0 • n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
24 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
24 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
22 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This analysis set included all subjects who were randomised, received at least one dose of trial medication and who provided at least one 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 BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
Reference 1 - BI 894416 Reference Formulation Tablet, Fasted
n=24 Participants
60 milligram (6 x 10 milligram tablets) BI 894416 Reference Formulation, immediate release (IR) tablets taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
Test 1 - BI 894416 Fast Release Rate (FRR) Tablet, Fasted
n=24 Participants
One single tablet of 62.5 milligram BI 894416 Formulation A2, extended release (ER) tablet (fast release rate (FRR)) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 2 - BI 894416 Slow Release Rate (SRR) Tablet, Fasted
n=24 Participants
One single tablet of 62.5 milligram BI 894416 Formulation C2, ER tablet (slow release rate (SRR)) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 3 - BI 894416 Fast Release Rate (FRR) Capsule, Fasted
n=24 Participants
One single capsule of 62.5 milligram BI 894416 Formulation D2, ER capsule (FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 4 - BI 894416 Slow Release Rate (SRR) Capsule, Fasted
n=24 Participants
One single capsule of 62.5 milligram BI 894416 Formulation F2, ER capsule (SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 5 - BI 894416 Slow Release Rate (SRR) Tablet, Fed
n=11 Participants
One single tablet of 62.5 milligram BI 894416 Formulation C2, ER tablet (SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.
|
Test 6 - BI 894416 Slow Release Rate (SRR) Capsule, Fed
n=13 Participants
One single capsule of 62.5 milligram BI 894416 Formulation F2, ER capsule (SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
9800 hour*nanomol/Liter
Geometric Coefficient of Variation 30.6
|
8260 hour*nanomol/Liter
Geometric Coefficient of Variation 29.6
|
7030 hour*nanomol/Liter
Geometric Coefficient of Variation 31.7
|
9100 hour*nanomol/Liter
Geometric Coefficient of Variation 33.3
|
7430 hour*nanomol/Liter
Geometric Coefficient of Variation 35.8
|
9680 hour*nanomol/Liter
Geometric Coefficient of Variation 31.1
|
8930 hour*nanomol/Liter
Geometric Coefficient of Variation 24.8
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This analysis set included all subjects who were randomised, received at least one dose of trial medication and who provided at least one 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 BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
Reference 1 - BI 894416 Reference Formulation Tablet, Fasted
n=24 Participants
60 milligram (6 x 10 milligram tablets) BI 894416 Reference Formulation, immediate release (IR) tablets taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
Test 1 - BI 894416 Fast Release Rate (FRR) Tablet, Fasted
n=24 Participants
One single tablet of 62.5 milligram BI 894416 Formulation A2, extended release (ER) tablet (fast release rate (FRR)) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 2 - BI 894416 Slow Release Rate (SRR) Tablet, Fasted
n=24 Participants
One single tablet of 62.5 milligram BI 894416 Formulation C2, ER tablet (slow release rate (SRR)) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 3 - BI 894416 Fast Release Rate (FRR) Capsule, Fasted
n=24 Participants
One single capsule of 62.5 milligram BI 894416 Formulation D2, ER capsule (FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 4 - BI 894416 Slow Release Rate (SRR) Capsule, Fasted
n=24 Participants
One single capsule of 62.5 milligram BI 894416 Formulation F2, ER capsule (SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 5 - BI 894416 Slow Release Rate (SRR) Tablet, Fed
n=11 Participants
One single tablet of 62.5 milligram BI 894416 Formulation C2, ER tablet (SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.
|
Test 6 - BI 894416 Slow Release Rate (SRR) Capsule, Fed
n=13 Participants
One single capsule of 62.5 milligram BI 894416 Formulation F2, ER capsule (SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
9780 hour*nanomol/Liter
Geometric Coefficient of Variation 30.5
|
8200 hour*nanomol/Liter
Geometric Coefficient of Variation 29.5
|
6950 hour*nanomol/Liter
Geometric Coefficient of Variation 31.8
|
9050 hour*nanomol/Liter
Geometric Coefficient of Variation 33.2
|
7310 hour*nanomol/Liter
Geometric Coefficient of Variation 36.3
|
9600 hour*nanomol/Liter
Geometric Coefficient of Variation 30.6
|
8850 hour*nanomol/Liter
Geometric Coefficient of Variation 24.9
|
Adverse Events
Reference 1 - BI 894416 Reference Formulation Tablet, Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Test 1 - BI 894416 Fast Release Rate (FRR) Tablet, Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Test 2 - BI 894416 Slow Release Rate (SRR) Tablet, Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test 3 - BI 894416 Fast Release Rate (FRR) Capsule, Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Test 4 - BI 894416 Slow Release Rate (SRR) Capsule, Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Test 5 - BI 894416 Slow Release Rate (SRR) Tablet, Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test 6 - BI 894416 Slow Release Rate (SRR) Capsule, Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference 1 - BI 894416 Reference Formulation Tablet, Fasted
n=24 participants at risk
60 milligram (6 x 10 milligram tablets) BI 894416 Reference Formulation, immediate release (IR) tablets taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
Test 1 - BI 894416 Fast Release Rate (FRR) Tablet, Fasted
n=24 participants at risk
One single tablet of 62.5 milligram BI 894416 Formulation A2, extended release (ER) tablet (fast release rate (FRR)) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 2 - BI 894416 Slow Release Rate (SRR) Tablet, Fasted
n=24 participants at risk
One single tablet of 62.5 milligram BI 894416 Formulation C2, ER tablet (slow release rate (SRR)) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 3 - BI 894416 Fast Release Rate (FRR) Capsule, Fasted
n=24 participants at risk
One single capsule of 62.5 milligram BI 894416 Formulation D2, ER capsule (FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 4 - BI 894416 Slow Release Rate (SRR) Capsule, Fasted
n=24 participants at risk
One single capsule of 62.5 milligram BI 894416 Formulation F2, ER capsule (SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Test 5 - BI 894416 Slow Release Rate (SRR) Tablet, Fed
n=11 participants at risk
One single tablet of 62.5 milligram BI 894416 Formulation C2, ER tablet (SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.
|
Test 6 - BI 894416 Slow Release Rate (SRR) Capsule, Fed
n=13 participants at risk
One single capsule of 62.5 milligram BI 894416 Formulation F2, ER capsule (SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
4.2%
1/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
8.3%
2/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
7.7%
1/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
4.2%
1/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
9.1%
1/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.2%
1/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
8.3%
2/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
4.2%
1/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
9.1%
1/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
4.2%
1/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
4.2%
1/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
7.7%
1/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
General disorders
Fatigue
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
9.1%
1/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
9.1%
1/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
7.7%
1/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
9.1%
1/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/24 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
9.1%
1/11 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
0.00%
0/13 • From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication. In accordance with the protocol, all study arms used the same active substance (BI 894416) in the same dosage and were combined for safety reporting as no safety issues were expected with any specific formulation.
|
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 Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER