Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo to BI 135585; Drug: BI 135585

Study type: Interventional

Funder types: Industry

Identifiers

NCT01146886

1283.1

2010-018856-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl. dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative bioavailability of two different immediate release tablet formulations versus oral solution (Part 2)

Enrollment: 60 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• healthy male volunteers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

BI 135585

Experimental group

Description:

1 single dose per subject as oral solution in Part 1, or 3 single doses per subject as oral solution and 2 different tablet formulations in Part 2

Treatment:

Drug: BI 135585

Placebo to BI 135585

Placebo Comparator group

Description:

1 single dose per subject as oral solution in Part 1

Treatment:

Drug: Placebo to BI 135585