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OpenTrials
Completed

NCT Number: NCT01541488

Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers

Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1310.1.1 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

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

BI 1021958

Drug

tablet

Placebo to BI 1021958

Drug

SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast

Primary outcomes

  1. Number of participants with clinically relevant findings in physical examination

    Time frame: up to 14 days postdose

  2. Number of participants with clinically relevant findings in vital signs

    Time frame: up to 14 days postdose

  3. Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results

    Time frame: up to 14 days postdose

  4. Number of participants with significant changes from baseline laboratory measurements

    Time frame: up to 14 days postdose

  5. Number of participants with adverse events

    Time frame: up to 14 days postdose

  6. Assessment of tolerability by investigator

    Time frame: up to 14 days postdose

Secondary outcomes

  1. Cmax (maximum measured concentration of BI 1021958 in plasma)

    Time frame: up to 72h postdose

  2. area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

    Time frame: up to 72h postdose

  3. AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)

    Time frame: up to 72h postdose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)

Important dates

Study start
2012
Primary completion
2012
First posted
Mar 1, 2012
Registry last updated
Oct 31, 2013

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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