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

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ClinicalTrials.gov Identifier: NCT02254148
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: midazolam Drug: caffeine Drug: digoxin Drug: warfarin Drug: omeprazole Drug: BI 187004 Drug: metoprolol Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arm Intervention/treatment
Experimental: Treatment
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
Drug: midazolam
single dose of midazolam given as oral solution (day 1 of visits 2 and 3)

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

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

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

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

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

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




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. healthy male subjects
  2. age of 18 to 55 years
  3. body mass index of 18.5 to 29.9 kg/m2
  4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

  1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
  2. 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
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
  7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254148


Locations
Germany
1307.19.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254148     History of Changes
Other Study ID Numbers: 1307.19
2013-005029-22 ( EudraCT Number: EudraCT )
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Midazolam
Caffeine
Metoprolol
Warfarin
Omeprazole
Digoxin
Krestin
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Anti-Ulcer Agents
Gastrointestinal Agents