Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects

Phase 1CompletedNCT01195688

Boehringer Ingelheim63 enrolled

Overview

The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

BI 638683 or placeboDRUG

oral doses given to 6 subjects per dose group

Placebo solutionDRUG

oral doses given to 2 subjects per dose group

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: healthy male subjects

Locations (1)

1279.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

Safety of BI 638683 will be assessed in a descriptive way.

Time frame: up to 14 days post treatment

Tolerability of BI 638683 will be assessed in a descriptive way.

Time frame: up to 14 days post treatment

Secondary Outcomes

To assess pharmacodynamics of BI 638683.

Time frame: up to 5 days post study drug administration

To assess pharmacokinetics of BI 638683.

Time frame: up to 5 days post study drug administration

Data from ClinicalTrials.gov

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