Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ketoconazole; Drug: BI 144807

Study type: Interventional

Funder types: Industry

Identifiers

NCT01707940

1313.7

2012-003225-21 (EudraCT Number)

Details and patient eligibility

About

This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.

Enrollment: 24 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

BI 144807

Experimental group

Description:

subjects receive an oral single dose of BI 144807

Treatment:

Drug: BI 144807

Drug: BI 144807

BI 144807 plus Ketoconazole

Experimental group

Description:

subjects receive bid ketoconazole plus an oral single dose of BI 144807

Treatment:

Drug: BI 144807

Drug: BI 144807

Drug: Ketoconazole