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Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin

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ClinicalTrials.gov Identifier: NCT02345304
Recruitment Status : Withdrawn
First Posted : January 26, 2015
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)

Condition or disease Intervention/treatment Phase
Healthy Drug: Omeprazole Drug: Warfarin Drug: BI 1181181 Drug: Midazolam Drug: Digoxin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Effects of BI 1181181 on the Pharmacokinetics of Midazolam, Warfarin, Omeprazole and Digoxin in Healthy Male Subjects
Study Start Date : March 2015
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Treatment 3
single dose of midazolam + BI drug
Drug: Midazolam
Drug: BI 1181181
Experimental: Treatment 4
single dose of probe drugs + BI drug
Drug: Omeprazole
Drug: Midazolam
Drug: BI 1181181
Drug: Warfarin
Experimental: Treatment 5
single dose of digoxin + BI drug
Drug: BI 1181181
Drug: Digoxin
Experimental: Treatment 1
single doses of probe drugs
Drug: Warfarin
Drug: Omeprazole
Drug: Midazolam
Experimental: Treatment 2
single dose of digoxin
Drug: Digoxin



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) of midazolam and omeprazol after each dosing [ Time Frame: up to 24 hours ]
  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) of digoxin after each dosing [ Time Frame: up to 96 hours ]
  3. 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) of warfarin after each dosing [ Time Frame: up to 120 hours ]
  4. Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing [ Time Frame: up to 24 hours ]
  5. Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing [ Time Frame: up to 96 hours ]
  6. Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing [ Time Frame: up to 120 hours ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • healthy male subjects
  • age of 18 to 50 years
  • body mass index (BMI) 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 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 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 the 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

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): NCT02345304


Locations
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Germany
1344.3.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02345304     History of Changes
Other Study ID Numbers: 1344.3
2014-004329-42 ( EudraCT Number: EudraCT )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Midazolam
Warfarin
Omeprazole
Digoxin
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
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Cardiotonic Agents
Protective Agents