Phase 1 Completed N=70 Randomized Single-blind Treatment

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers

Healthy

Source: ClinicalTrials.gov NCT01594515 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcomePrimary: Number (%) of Subjects With Drug Related Adverse Events — 0.0; 33.3; 16.7; 0.0 Percentage of Participants

Summary

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number (%) of Subjects With Drug Related Adverse Events	0.0; 33.3; 16.7; 0.0; 0.0; 33.3	—
PRIMARY Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Cmax of BI 1015550	NA; 1.42; 5.02; 13.7; 46.9; 113	—
SECONDARY AUC0-infinity of BI 1015550	NA; 7.44; 24.1; 67.9; 287; 679	—

Eligibility Criteria

Inclusion criteria

Healthy male subjects

Exclusion criteria

Any relevant deviation from healthy conditions

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Data sourced from ClinicalTrials.gov (NCT01594515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.