ClinicalTrials.Veeva

Menu

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 logo

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems