Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 163538 XX; Drug: Placebo to BI 163538 XX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01587391

1291.1

2011-006184-22 (EudraCT Number)

Details and patient eligibility

About

To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range

Enrollment: 48 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects
2. overweight or obese

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

BI 163538 XX

Experimental group

Description:

1 single dose per subject as oral solution

Treatment:

Drug: BI 163538 XX

Placebo to BI 163538 XX

Placebo Comparator group

Description:

1 single dose per subject as oral solution

Treatment:

Drug: Placebo to BI 163538 XX