Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 113608 PIB bid; Drug: BI 113608 PIB qd; Drug: Placebo to BI 113608 PIB bid; Drug: Placebo to BI 113608 PIB qd

Study type: Interventional

Funder types: Industry

Identifiers

NCT01681277

2012-002536-82 (EudraCT Number)

1314.2

Details and patient eligibility

About

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Enrollment: 48 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: Double Blind

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48 participants in 4 patient groups

BI 113608 high dose bid

Experimental group

Description:

powder in the bottle for oral solution, oral administration with 240 ml water

Treatment:

Drug: BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

Drug: BI 113608 PIB bid

Drug: BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

BI 113608 low dose bid

Experimental group

Description:

powder in the bottle for oral solution, oral administration with 240 ml water

Treatment:

Drug: BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

Drug: BI 113608 PIB bid

Drug: BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

BI 113608 medium dose bid

Experimental group

Description:

powder in the bottle for oral solution, oral administration with 240 ml water

Treatment:

Drug: BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

Drug: BI 113608 PIB bid

Drug: BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

Drug: Placebo to BI 113608 PIB bid

BI 113608 high dose qd

Experimental group

Description:

powder in the bottle for oral solution, oral administration with 240 ml water

Treatment:

Drug: Placebo to BI 113608 PIB qd

Drug: BI 113608 PIB qd