Safety Tolerability and Pharmacokinetic of BI 411034

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 411034; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01581684

2011-004840-23 (EudraCT Number)

1308.1

Details and patient eligibility

About

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Enrollment: 62 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: Single Group Assignment

Masking: Single Blind

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62 participants in 9 patient groups, including a placebo group

BI 411034 low dose - group 1

Experimental group

Description:

Solution for oral administration

Treatment:

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

BI 411034 low dose - group 2

Experimental group

Description:

Solution for oral administration

Treatment:

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

BI 411034 medium dose - group 3

Experimental group

Description:

Solution for oral administration

Treatment:

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

BI 411034 medium dose - group 4

Experimental group

Description:

Solution for oral administration

Treatment:

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

BI 411034 medium dose - group 5

Experimental group

Description:

Solution for oral administration

Treatment:

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

BI 411034 high dose - group 6

Experimental group

Description:

Solution for oral administration

Treatment:

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

BI 411034 high dose - group 7

Experimental group

Description:

Solution for oral administration

Treatment:

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

BI 411034 high dose - group 8

Experimental group

Description:

Solution for oral administration

Treatment:

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Drug: BI 411034

Placebo

Placebo Comparator group

Description:

Solution for oral administration

Treatment:

Drug: Placebo