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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI1015550; Drug: BI 1015550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01835899

2012-005614-19 (EudraCT Number)

1305.2

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions
2. Subjects unable to understand or to comply with study requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 5 patient groups

Placebo to BI 1015550

Experimental group

Description:

placebo

Treatment:

Drug: Placebo

BI 1015550 low dose 1

Experimental group

Description:

powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 low dose 2

Experimental group

Description:

powder for oral solution

Treatment:

Drug: BI1015550

BI 1015550 medium dose 1

Experimental group

Description:

powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 medium dose 2

Experimental group

Description:

powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550