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Completed

NCT Number: NCT02222168

Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers

To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1289.22.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female volunteers
  • Age 18 (incl.) to 50 (incl.) years
  • Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria

  • Any evidence of a clinically relevant concomitant disease
  • Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
  • History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
  • Positive pregnancy test
  • No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)

Treatment and study plan

BI 409306

Drug

film-coated tablet

Primary outcomes

  1. Maximum Measured Concentration of BI 409306 in Plasma (Cmax)

    Time frame: Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h

    Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C

  2. Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz)

    Time frame: Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h

    AUC0-tz is the area under the concentration-time curve of the BI 409306 in plasma from time 0 to time of last quantifiable data point.

    More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C

Secondary outcomes

  1. Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)

    Time frame: Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h

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

    More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Open, Randomised, Two-way Crossover Study to Assess the Effect of a High Fat, High Caloric Meal on the Pharmacokinetics of BI 409306, Followed by a Fixed Sequence Period to Investigate the Pharmacokinetics of BI 409306 After a Single Oral Dose Given at Bed Time in Healthy Male and Female Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2014
Registry last updated
Jul 31, 2024

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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