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OpenTrials
Completed

NCT Number: NCT01195688

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

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1279.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy male subjects

Treatment and study plan

BI 638683 or placebo

Drug

oral doses given to 6 subjects per dose group

Placebo solution

Drug

oral doses given to 2 subjects per dose group

Primary outcomes

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

    Time frame: up to 14 days post treatment

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

    Time frame: up to 14 days post treatment

Secondary outcomes

  1. To assess pharmacodynamics of BI 638683.

    Time frame: up to 5 days post study drug administration

  2. To assess pharmacokinetics of BI 638683.

    Time frame: up to 5 days post study drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2010
Primary completion
2010
First posted
Sep 6, 2010
Registry last updated
Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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