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Completed

NCT Number: NCT01594515

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

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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

1305.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, 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 1015550

Drug

High dose powder for oral solution

Placebo

Drug

Solution for oral administration

BI 101550

Drug

High dose powder for oral solution

Primary outcomes

  1. Number (%) of Subjects With Drug Related Adverse Events

    Time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.

    Percentage of subjects with drug related adverse events.

  2. Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests

    Time frame: Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).

    Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).

  3. Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs

    Time frame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).

    Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).

  4. Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs

    Time frame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).

    Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.

  5. Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability

    Time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.

    Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.

  6. Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations

    Time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.

    Percentage of subjects with clinically relevant abnormalities in physical examinations.

Secondary outcomes

  1. Cmax of BI 1015550

    Time frame: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

    Maximum measured concentration of the analyte in plasma.

  2. AUC0-infinity of BI 1015550

    Time frame: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 9, 2012
Registry last updated
Dec 15, 2015

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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