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Completed

NCT Number: NCT02254148

The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)

To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1307.19.1 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 male subjects
  • age of 18 to 55 years
  • body mass index of 18.5 to 29.9 kg/m2
  • Subjects must be able to understand and comply with study requirements

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Treatment and study plan

midazolam

Drug

single dose of midazolam given as oral solution (day 1 of visits 2 and 3)

Caffeine

Drug

single dose of caffeine given as tablets (day 1 of visits 2 and 3)

Digoxin

Drug

single dose of digoxin given as tablets (day 3 of visits 2 and 3)

Warfarin

Drug

single dose of warfarin given as tablets (day 1 of visits 2 and 3)

Omeprazole

Drug

single dose of omeprazole given as tablet (day 1 of visits 2 and 3)

BI 187004

Drug

multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)

metoprolol

Drug

single dose of metoprolol given as tablets (day 1 of visits 2 and 3)

Primary outcomes

  1. 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) for probe substrates

    Time frame: up to 143 hours postdose

  2. Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates

    Time frame: up to 143 hours postdose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Effect of Multiple Doses of BI 187004 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P-glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2014
Registry last updated
Dec 23, 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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