Trial Outcomes & Findings for A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood (NCT NCT03892616)
NCT ID: NCT03892616
Last Updated: 2025-02-28
Results Overview
Maximum measured concentration of BI 1358894 in plasma (Cmax).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.
Results posted on
2025-02-28
Participant Flow
This open-label, single-dose, randomized, incomplete blocks crossover design study in healthy male was to test if taking different tablet formulations (TF1, TF2a, and TF2b) of BI 1358894 with or without food influences the amount of BI 1358894 in the blood.
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 |
TF1 Fed (A)-TF2a Fed (B)-TF2a Fasted (C)
1 tablet of 100 milligram (mg) BI 1358894 was administrated as a single oral dose with 240 milliliter (mL) water 30 minutes (min) after a high-fat, high-calorie breakfast as treatment A (TF1; fed conditions) followed by a washout period of at least 17 days, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 hours (h) (TF2a fasted conditions) as treatment C.
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TF2b Fed (D)-TF1 Fed (A)-TF2a Fed (B)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
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TF2b Fasted (E)-TF2a Fed (B)-TF1 Fed (A)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by washout period of at least 17 days, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
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TF2a Fasted (C)- TF1 Fed (A)-TF2b Fed (D)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by washout period of at least 17 days, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
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TF1 Fed (A)- TF2b Fasted (E)- TF2a Fasted (C)
1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C.
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TF2b Fasted (E)-TF2b Fed (D)- TF1 Fed (A)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
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TF2a Fed (B)- TF2a Fasted (C)-TF2b Fed (D)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
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TF2a Fasted(C)-TF2b Fasted(E)-TF2a Fed(B)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
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TF2a Fed(B)-TF2b Fed(D)-TF2b Fasted(E)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
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TF2b Fed(D)-TF2a Fasted(C)-TF2b Fasted(E)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
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TF2a Fasted(C)-TF2a Fed(B)-TF1 Fed(A)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
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TF1 Fed (A)- TF2b Fasted (E)-TF2b Fed (D)
1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
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Treatment Period 1
STARTED
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Treatment Period 1
COMPLETED
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Treatment Period 1
NOT COMPLETED
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Washout Period 1
STARTED
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Washout Period 1
COMPLETED
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Washout Period 1
NOT COMPLETED
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Treatment Period 2
STARTED
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Treatment Period 2
COMPLETED
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Treatment Period 2
NOT COMPLETED
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Washout Period 2
STARTED
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Washout Period 2
COMPLETED
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Washout Period 2
NOT COMPLETED
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Treatment Period 3
STARTED
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Treatment Period 3
COMPLETED
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Treatment Period 3
NOT COMPLETED
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Reasons for withdrawal
| Measure |
TF1 Fed (A)-TF2a Fed (B)-TF2a Fasted (C)
1 tablet of 100 milligram (mg) BI 1358894 was administrated as a single oral dose with 240 milliliter (mL) water 30 minutes (min) after a high-fat, high-calorie breakfast as treatment A (TF1; fed conditions) followed by a washout period of at least 17 days, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 hours (h) (TF2a fasted conditions) as treatment C.
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TF2b Fed (D)-TF1 Fed (A)-TF2a Fed (B)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
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TF2b Fasted (E)-TF2a Fed (B)-TF1 Fed (A)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by washout period of at least 17 days, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
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TF2a Fasted (C)- TF1 Fed (A)-TF2b Fed (D)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by washout period of at least 17 days, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
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TF1 Fed (A)- TF2b Fasted (E)- TF2a Fasted (C)
1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C.
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TF2b Fasted (E)-TF2b Fed (D)- TF1 Fed (A)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
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TF2a Fed (B)- TF2a Fasted (C)-TF2b Fed (D)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
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TF2a Fasted(C)-TF2b Fasted(E)-TF2a Fed(B)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
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TF2a Fed(B)-TF2b Fed(D)-TF2b Fasted(E)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
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TF2b Fed(D)-TF2a Fasted(C)-TF2b Fasted(E)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
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TF2a Fasted(C)-TF2a Fed(B)-TF1 Fed(A)
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
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TF1 Fed (A)- TF2b Fasted (E)-TF2b Fed (D)
1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
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Washout Period 2
Met discontinuation criterion
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Baseline Characteristics
A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood
Baseline characteristics by cohort
| Measure |
TF1 Fed (A)-TF2a Fed (B)-TF2a Fasted (C)
n=2 Participants
1 tablet of 100 milligram (mg) BI 1358894 was administrated as a single oral dose with 240 milliliter (mL) water 30 minutes (min) after a high-fat, high-calorie breakfast as treatment A (TF1; fed conditions) followed by a washout period of at least 17 days, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 hours (h) (TF2a fasted conditions) as treatment C.
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TF2b Fed (D)-TF1 Fed (A)-TF2a Fed (B)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
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TF2b Fasted (E)-TF2a Fed (B)-TF1 Fed (A)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by washout period of at least 17 days, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
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TF2a Fasted (C)- TF1 Fed (A)-TF2b Fed (D)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by washout period of at least 17 days, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
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TF1 Fed (A)- TF2b Fasted (E)- TF2a Fasted (C)
n=2 Participants
1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C.
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TF2b Fasted (E)-TF2b Fed (D)- TF1 Fed (A)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
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TF2a Fed (B)- TF2a Fasted (C)-TF2b Fed (D)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
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TF2a Fasted(C)-TF2b Fasted(E)-TF2a Fed(B)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
|
TF2a Fed(B)-TF2b Fed(D)-TF2b Fasted(E)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
|
TF2b Fed(D)-TF2a Fasted(C)-TF2b Fasted(E)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
|
TF2a Fasted(C)-TF2a Fed(B)-TF1 Fed(A)
n=2 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2a; fasted conditions) as treatment C followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B followed by at least 17 days of washout, followed by 1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A.
|
TF1 Fed (A)- TF2b Fasted (E)-TF2b Fed (D)
n=2 Participants
1 tablet of 100 mg BI 1358894 was administrated as a single oral dose with 240mL water 30 min after a high-fat, high-calorie breakfast (TF1; fed conditions) as treatment A followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E followed by at least 17 days of washout, followed by 2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.5 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
46.0 Years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
43.0 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
46.0 Years
STANDARD_DEVIATION 0.0 • n=4 Participants
|
41.0 Years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
46.5 Years
STANDARD_DEVIATION 0.7 • n=8 Participants
|
33.0 Years
STANDARD_DEVIATION 18.4 • n=8 Participants
|
46.0 Years
STANDARD_DEVIATION 5.7 • n=24 Participants
|
48.5 Years
STANDARD_DEVIATION 2.1 • n=42 Participants
|
35.5 Years
STANDARD_DEVIATION 20.5 • n=42 Participants
|
35.5 Years
STANDARD_DEVIATION 10.6 • n=42 Participants
|
47.0 Years
STANDARD_DEVIATION 4.2 • n=42 Participants
|
42.3 Years
STANDARD_DEVIATION 9.0 • n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
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=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
24 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
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=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
24 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
24 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included 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 BI 1358894 in plasma (Cmax).
Outcome measures
| Measure |
TF1 Fed (A)
n=16 Participants
1 tablet of 100 milligram (mg) BI 1358894 was administrated as a single oral dose with 240 milliliter (mL) water 30 min after a high-fat, high-calorie breakfast (Tablet formulation 1 (TF1); fed conditions) as treatment A.
|
TF2a Fed (B)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
|
TF2a Fasted (C)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 hours (h) (TF2a; fasted conditions) as treatment C.
|
TF2b Fed (D)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
|
TF2b Fasted (E)
n=13 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
|
|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)
|
497 Nanomole (nmol) / Litre (L)
Standard Error 1.07
|
556 Nanomole (nmol) / Litre (L)
Standard Error 1.08
|
484 Nanomole (nmol) / Litre (L)
Standard Error 1.08
|
604 Nanomole (nmol) / Litre (L)
Standard Error 1.08
|
909 Nanomole (nmol) / Litre (L)
Standard Error 1.08
|
PRIMARY outcome
Timeframe: Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included 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. Only participants with available PK data are included in the analysis.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
TF1 Fed (A)
n=16 Participants
1 tablet of 100 milligram (mg) BI 1358894 was administrated as a single oral dose with 240 milliliter (mL) water 30 min after a high-fat, high-calorie breakfast (Tablet formulation 1 (TF1); fed conditions) as treatment A.
|
TF2a Fed (B)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
|
TF2a Fasted (C)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 hours (h) (TF2a; fasted conditions) as treatment C.
|
TF2b Fed (D)
n=13 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
|
TF2b Fasted (E)
n=13 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
17695 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.04
|
18934 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.04
|
10645 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.04
|
19356 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.04
|
12655 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.04
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included 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. Only participants with available PK data are included in the analysis.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
TF1 Fed (A)
n=16 Participants
1 tablet of 100 milligram (mg) BI 1358894 was administrated as a single oral dose with 240 milliliter (mL) water 30 min after a high-fat, high-calorie breakfast (Tablet formulation 1 (TF1); fed conditions) as treatment A.
|
TF2a Fed (B)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
|
TF2a Fasted (C)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 hours (h) (TF2a; fasted conditions) as treatment C.
|
TF2b Fed (D)
n=13 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
|
TF2b Fasted (E)
n=13 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
19425 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.04
|
20596 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.04
|
11715 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.04
|
20752 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.05
|
13818 Nanomole (nmol)*hours(h)/Litre(L)
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration in each treatment period.Population: Pharmacokinetic (PK) parameter analysis set (PKS) included 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 BI 1358894 in plasma over the time interval from 0 to 72 hours (AUC0-72).
Outcome measures
| Measure |
TF1 Fed (A)
n=16 Participants
1 tablet of 100 milligram (mg) BI 1358894 was administrated as a single oral dose with 240 milliliter (mL) water 30 min after a high-fat, high-calorie breakfast (Tablet formulation 1 (TF1); fed conditions) as treatment A.
|
TF2a Fed (B)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
|
TF2a Fasted (C)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 hours (h) (TF2a; fasted conditions) as treatment C.
|
TF2b Fed (D)
n=14 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
|
TF2b Fasted (E)
n=13 Participants
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
|
11742 Nanomole (nmol) * hours (h) / Litre (L)
Standard Error 1.04
|
12297 Nanomole (nmol) * hours (h) / Litre (L)
Standard Error 1.05
|
6635 Nanomole (nmol) * hours (h) / Litre (L)
Standard Error 1.05
|
13109 Nanomole (nmol) * hours (h) / Litre (L)
Standard Error 1.05
|
8273 Nanomole (nmol) * hours (h) / Litre (L)
Standard Error 1.05
|
Adverse Events
TF1 Fed (A)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
TF2a Fed (B)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
TF2a Fasted (C)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
TF2b Fed (D)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
TF2b Fasted (E)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TF1 Fed (A)
n=16 participants at risk
1 tablet of 100 milligram (mg) BI 1358894 was administrated as a single oral dose with 240 milliliter (mL) water 30 min after a high-fat, high-calorie breakfast (Tablet formulation 1 (TF1); fed conditions) as treatment A.
|
TF2a Fed (B)
n=14 participants at risk
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2a; fed conditions) as treatment B.
|
TF2a Fasted (C)
n=14 participants at risk
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 hours (h) (TF2a; fasted conditions) as treatment C.
|
TF2b Fed (D)
n=14 participants at risk
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water 30 min after a high-fat, high-calorie breakfast (TF2b; fed conditions) as treatment D.
|
TF2b Fasted (E)
n=13 participants at risk
2 tablets of 50mg BI 1358894 (total: 100mg) administrated as a single oral dose with 240 mL water after an overnight fast of at least 10 h (TF2b; fasted conditions) as treatment E.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
31.2%
5/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
42.9%
6/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
35.7%
5/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
42.9%
6/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
23.1%
3/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.7%
1/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
14.3%
2/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.7%
1/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.7%
1/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.7%
1/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
General disorders
Fatigue
|
0.00%
0/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
7.1%
1/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/14 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
0.00%
0/13 • From drug administration until the next drug administration, or until the end of the trial, up to 22 days.
The treated set (TS) included all subjects who were randomized and treated with at least 1 dose of trial medication. The TS was used for the presentation of demographic and baseline characteristics and for the safety analyses.
|
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