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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 101550; Drug: BI 1015550; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594515

2012-000405-68 (EudraCT Number)

1305.1

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 10 patient groups, including a placebo group

BI 1015550 low dose A

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 low dose B

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 low dose C

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 low dose D

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 medium dose A

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 medium dose B

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 medium dose C

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 high dose A

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

Drug: BI 1015550

BI 1015550 high dose B

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 101550

Placebo

Placebo Comparator group

Description:

Solution for oral administration

Treatment:

Drug: Placebo