Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 144807 high dose; Drug: BI 144807 intermediate dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01897597

1313.9

2013-000258-23 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects

Exclusion criteria

• Any relevant deviation from healthy condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 7 patient groups

BI 144807 PfoS Treatment A

Experimental group

Description:

intermediate dose of BI 144807

Treatment:

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

BI 144807 PfoS Treatment C

Experimental group

Description:

high dose of BI 144807

Treatment:

Drug: BI 144807 high dose

Drug: BI 144807 high dose

BI 144807 Tab Treatment B

Experimental group

Description:

intermediate dose of BI 144807

Treatment:

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

BI 144807 Tab Treatment D

Experimental group

Description:

high dose of BI 144807

Treatment:

Drug: BI 144807 high dose

Drug: BI 144807 high dose

BI 144807 Tab Treatment E

Experimental group

Description:

intermediate dose of BI 144807, fasted

Treatment:

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

BI 144807 Tab Treatment F

Experimental group

Description:

intermediate dose of BI 144807, fed

Treatment:

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

BI 144807 Tab Treatment G

Experimental group

Description:

intermediate dose of BI 144807, fasted

Treatment:

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose

Drug: BI 144807 intermediate dose