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OpenTrials
Completed

NCT Number: NCT01835899

Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution

To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

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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

1305.2.1 Boehringer Ingelheim Investigational Site

Mannheim, 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
  • Subjects unable to understand or to comply with study requirements

Treatment and study plan

Placebo

Drug

Placebo to BI 1015550

BI 1015550

Drug

medium dose 1 powder for oral solution

BI1015550

Drug

low dose 2 powder for oral solution

Primary outcomes

  1. Percentage of Subjects With Drug-related Adverse Events

    Time frame: From first drug administration until last drug administration, upto 18 days.

    Percentage of subjects with drug related Adverse events, as assessed by the investigator.

Secondary outcomes

  1. Cmax

    Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.

    Maximum measured concentration of BI 1015550 in plasma.

  2. AUCt,1

    Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration

    Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose

  3. AUC0-infinity

    Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.

    Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.

  4. Cmax,ss

    Time frame: 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.

    Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.

  5. AUCt,ss

    Time frame: 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.

    Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d.for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2013
Registry last updated
Jan 22, 2016

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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