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Completed

NCT Number: NCT01971502

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469

The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1333.1.1 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 males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
  • Age within the range of 18 to 50 years
  • Body mass index within the range of 18.5 and 29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation.

Exclusion criteria

  • Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • In the SRD: serum creatinine laboratory value outside the normal range
  • Glomerular filtration rate (GFR) according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration)-Formula < 60 ml/ min
  • Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug

Treatment and study plan

Placebo to BI 1060469

Drug

single rising doses

BI 1060469

Drug

food effect

Primary outcomes

  1. Number of subjects with drug- related adverse events.

    Time frame: up to 2 weeks

Secondary outcomes

  1. Cmax (maximum measured concentration of BI 1060469 in plasma)

    Time frame: up to 2 weeks

  2. AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 2 weeks

  3. AUC0-tz (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 up to the last quantifiable data point)

    Time frame: up to 2 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of BI 1060469 in Healthy Male Volunteers (Single-blind, Placebo-controlled, Randomised, Partly Fixed-sequence, Parallel Group Design) and Effect of Food on the Bioavailability of BI 1060469 (Open-label, Randomised, Two-way Cross-over)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2013
Registry last updated
Oct 27, 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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