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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1015550; Drug: BI 101550; Drug: Placebo

• Registration Number: NCT01594515
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-11
• Results First Submitted: 2015-11-11
• Results First Submitted QC: 2015-11-11
• Last Update Submitted: 2015-11-11
• Results First Posted: 2015-12-15
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1015550 low dose A	BI 1015550	Powder for oral solution
BI 1015550 low dose C	BI 1015550	Powder for oral solution
BI 1015550 low dose D	BI 1015550	Powder for oral solution
BI 1015550 medium dose A	BI 1015550	Powder for oral solution
BI 1015550 high dose B	BI 101550	Powder for oral solution
Placebo	Placebo	Solution for oral administration
BI 1015550 low dose B	BI 1015550	Powder for oral solution
BI 1015550 medium dose B	BI 1015550	Powder for oral solution
BI 1015550 medium dose C	BI 1015550	Powder for oral solution
BI 1015550 high dose A	BI 1015550	Powder for oral solution

Primary Outcome Measures

Name	Time	Method
Number (%) of Subjects With Drug Related Adverse Events	From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.	Percentage of subjects with drug related adverse events.
Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests	Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).	Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).
Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs	Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).	Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).
Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs	Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).	Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.
Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability	From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.	Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.
Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations	From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.	Percentage of subjects with clinically relevant abnormalities in physical examinations.

Secondary Outcome Measures

Name	Time	Method
Cmax of BI 1015550	-0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing	Maximum measured concentration of the analyte in plasma.
AUC0-infinity of BI 1015550	-0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing	Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity

Trial Locations

Locations (1)

1305.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany