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Completed

NCT Number: NCT02044406

Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181

To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1344.1.1 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 males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests
  • Age 18 to 50 years (incl.)
  • Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening
  • Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening
  • Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Treatment and study plan

BI 1181181

Drug

single dose (low to high dose)

BI 1181181, R

Drug

powder for oral solution

BI 1181181, T2

Drug

tablet, fasted

Placebo to BI 1181181

Drug

Placebo to BI 1181181

BI 1181181, T1

Drug

tablet, fed

Primary outcomes

  1. Number (%) of subjects with drug-related adverse events (AEs)

    Time frame: up to 72 h

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

    Time frame: up to 72 h

  3. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 72 h

Secondary outcomes

  1. Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration)

    Time frame: up to 72 h

  2. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 72 h

  3. tmax (time from dosing to maximum measured concentration of the analyte in plasma)

    Time frame: up to 72 h

  4. AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 72 h

  5. t1/2 (terminal half-life of the analyte in plasma)

    Time frame: up to 72 h

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability and the Effect of Food on the Pharmacokinetics of BI 1181181(Open-label, Randomised, Three-way Cross-over Design)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2014
Registry last updated
Oct 8, 2014

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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