First in Man Trial of BI 113608

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 113608

Study type: Interventional

Funder types: Industry

Identifiers

NCT01540825

1314.1

2011-005034-19 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Enrollment: 80 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 11 patient groups, including a placebo group

BI 113608 high dose 1

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 low dose 1

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 low dose 2

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 low dose 4

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 low dose 5

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 medium dose 1

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 medium dose 2

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 medium dose 3

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 high dose 2

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

BI 113608 high dose 3

Experimental group

Description:

Powder for oral solution

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Placebo

Placebo Comparator group

Description:

Powder for oral solution

Treatment:

Drug: Placebo