Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Voriconazole; Drug: Ketoconazole; Drug: BI 113608

Study type: Interventional

Funder types: Industry

Identifiers

NCT01787032

2012-002538-36 (EudraCT Number)

1314.7

Details and patient eligibility

About

The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.

Enrollment: 20 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: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Period 3: BI 113608+Voriconazole

Experimental group

Description:

tablets with 240 ml water

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: Voriconazole

Drug: BI 113608

Period 2: BI 113608+Ketoconazole

Experimental group

Description:

tablets with 240 ml water

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: Ketoconazole

Period 1: BI 113608

Experimental group

Description:

tablets with 240 ml water

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608