Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 113823; Drug: BI 113823 + Ketokonazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189175

2010-018542-31 (EudraCT Number)

1272.5

Details and patient eligibility

About

The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823

Enrollment: 16 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

healthy male subjects

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

BI 113823

Experimental group

Description:

single oral dose per subject

Treatment:

Drug: BI 113823

BI 113823 + Ketokonazole

Experimental group

Description:

after wash-out 5 days ketokonazole with BI 113823 on day 3

Treatment:

Drug: BI 113823 + Ketokonazole