Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 144807; Drug: BI 144807 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01480648

1313.1

2011-002560-24 (EudraCT Number)

Details and patient eligibility

About

This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.

Enrollment: 74 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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74 participants in 2 patient groups, including a placebo group

BI144807

Experimental group

Description:

Subjects receive a single oral dose of BI144807solution

Treatment:

Drug: BI 144807

Placebo

Placebo Comparator group

Description:

Subjects receive a single oral dose of placebo solution

Treatment:

Drug: BI 144807 Placebo