A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities
NCT ID: NCT06107036
Last Updated: 2025-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2024-03-06
2024-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sequence 1: H/M/P2/L/P1
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 2: H/P1/L/P2/M
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 3: H/L/P2/M/P1
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 4: M/H/L/P1/P2
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 5: M/P1/L/H/P2
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 6: M/P2/H/L/P1
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 7: P1/M/H/P2/L
Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 8: P1/P2/H/M/L
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 9: P1/L/M/H/P2
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 10: P2/H/P1/M/L
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 11: P2/P1/M/L/H
Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 12: P2/L/M/P1/H
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 13: L/H/P1/P2/M
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 14: L/M/P2/P1/H
Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Sequence 15: L/P2/P1/H/M
Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Interventions
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BI 1015550
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age of 18 to 50 years (inclusive)
3. Body mass index of 18.5 to 32 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
5. Either male subjects, or female subjects meet the following criteria requiring highly effective contraception from at least 30 days before the first administration of trial medication until 37 days after the last administration of the study drug:
* Male participants must use condom plus their partner, if identified as a women of childbearing potential (WOCBP), must use an oral contraceptive or highly effective contraception
* Female participants must be using highly effective contraception and in addition their male partner must use a condom if they are using an oral contraceptive
Exclusion Criteria
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or heart rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase, aspartate transaminase, total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behaviour
18 Years
50 Years
ALL
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Quotient Sciences
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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U1111-1295-4664
Identifier Type: REGISTRY
Identifier Source: secondary_id
1305-0026
Identifier Type: -
Identifier Source: org_study_id
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