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

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1-700 mg) of BI 638683 Powder in Bottle (PiB) in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01195688

Enrollment

Registered

2010-09-06

Start date

2010-09-30

Completion date

Unknown

Last updated

2011-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGBI 638683 or placebo

oral doses given to 6 subjects per dose group

DRUGPlacebo solution

oral doses given to 2 subjects per dose group

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

healthy male subjects

Design outcomes

Primary

Measure	Time frame
Safety of BI 638683 will be assessed in a descriptive way.	up to 14 days post treatment
Tolerability of BI 638683 will be assessed in a descriptive way.	up to 14 days post treatment

Secondary

Measure	Time frame
To assess pharmacodynamics of BI 638683.	up to 5 days post study drug administration
To assess pharmacokinetics of BI 638683.	up to 5 days post study drug administration

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026