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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 638683 or placebo; Drug: Placebo solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01195688

1279.1

2010-021187-15 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

healthy male subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

63 participants in 2 patient groups, including a placebo group

BI 638683

Experimental group

Description:

1 single dose per subject as oral solution

Treatment:

Drug: BI 638683 or placebo

Placebo solution

Placebo Comparator group

Description:

1 single dose per subject as oral solution

Treatment:

Drug: Placebo solution