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

NCT02254148 | Completed Phase 1

• 2 other identifiers: 1307.192013-005029-22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (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) for probe substrates

  up to 143 hours postdose

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

  up to 143 hours postdose

Study Arms (1)

Treatment

EXPERIMENTAL

single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004

Drug: midazolam; Drug: caffeine; Drug: digoxin; Drug: warfarin; Drug: omeprazole; Drug: BI 187004; Drug: metoprolol

Interventions

midazolam DRUG

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

Treatment

caffeine DRUG

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

Treatment

digoxin DRUG

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

Treatment

warfarin DRUG

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

Treatment

omeprazole DRUG

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

Treatment

BI 187004 DRUG

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

Treatment

metoprolol DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1307.19.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

Midazolam; Caffeine; Digoxin; Warfarin; Omeprazole; Metoprolol

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Xanthines; Alkaloids; Purinones; Purines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 1, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

DE (1)