Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BI 1015550; Drug: BI1015550

• Registration Number: NCT01835899
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-19
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2015-11-11
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-16
• Last Update Submitted: 2015-12-16
• Results First Posted: 2016-01-22
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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
Placebo to BI 1015550	Placebo	placebo
BI 1015550 low dose 1	BI 1015550	powder for oral solution
BI 1015550 low dose 2	BI1015550	powder for oral solution
BI 1015550 medium dose 1	BI 1015550	powder for oral solution
BI 1015550 medium dose 2	BI 1015550	powder for oral solution

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug-related Adverse Events	From first drug administration until last drug administration, upto 18 days.	Percentage of subjects with drug related Adverse events, as assessed by the investigator.

Secondary Outcome Measures

Name	Time	Method
AUCt,1	0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration	Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose
AUC0-infinity	0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.	Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.
Cmax,ss	311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.	Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.
AUCt,ss	311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.	Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.
Cmax	0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.	Maximum measured concentration of BI 1015550 in plasma.

Trial Locations

Locations (1)

1305.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany