Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers

NCT ID: NCT02256813

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30

Brief Summary

The study aimed to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 on the Pharmacokinetics (PK) of five probe substrates for cytochrome P450 isozymes.

The substrates used to monitor enzyme activity were oral warfarin (for CYP2C9), oral omeprazole (for CYP2C19), oral dextromethorphan (for CYP2D6), oral caffeine (for CYP1A2) and intravenous midazolam (for hepatic CYP3A)

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIRT 2584 XX + PK-cocktail

Group Type: EXPERIMENTAL

BIRT 2584 XX

Intervention Type: DRUG

Warfarin sodium

Intervention Type: DRUG

Omeprazole

Intervention Type: DRUG

Dextromethorphan hydrobromide

Intervention Type: DRUG

Caffeine

Intervention Type: DRUG

Midazolam hydrochloride

Intervention Type: DRUG

Vitamin K1

Intervention Type: DRUG

Interventions

BIRT 2584 XX

Intervention Type: DRUG

Warfarin sodium

Intervention Type: DRUG

Omeprazole

Intervention Type: DRUG

Dextromethorphan hydrobromide

Intervention Type: DRUG

Caffeine

Intervention Type: DRUG

Midazolam hydrochloride

Intervention Type: DRUG

Vitamin K1

Intervention Type: DRUG

Other Intervention Names

Coumadin®; Omeprazole-ratiopharm® NT; Hustenstiller-ratiopharm®; Coffeinum®; Dormicum®; Konakion®

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 and ≤55 years
• BMI ≥ 18.5 and ≤ 29.9 kg/m2
• healthy male subjects as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG at the screening visit
• signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• non-smoker (a subject is considered to be a non-smoker if he has never smoked or has stopped smoking ≥ 6 months before the screening visit)
• agree not to take any prescription medications or non-prescription drugs (including herbal preparations and vitamins) without approval by the investigator and not to receive vaccinations during the course of the study
• agree not to eat oranges, grapefruits, broccoli, Brussels sprouts, or char grilled meats and not to drink grapefruit juice during the course of the study
• agree not to drink alcoholic beverages during the course of the study
• agree not to drink or eat caffeine and theobromine containing beverages and foods during the course of the study

Exclusion Criteria

• any finding of the medical examination (including Blood Pressure, Pulse Rate, and ECG) deviating from normal and of clinical relevance
• gastrointestinal, hepatic, renal, respiratory (e.g. asthma), cardiovascular, metabolic, immunologic, haematological, oncological, or hormonal disorders
• any surgical or medical condition that could interfere with the administration of the study drug or interpretation of the study results
• diseases of the Central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders
• relevant history of orthostatic hypotension, fainting spells, or blackouts
• chronic or relevant acute infections
• history of allergy/hypersensitivity (including drug allergy) considered relevant to the trial as judged by the investigator
• immunisation during the 2 weeks prior to the screening visit
• known intolerance to benzodiazepines
• known intolerance to the active and/or inactive ingredients in caffeine, warfarin, vitamin K1, omeprazole, or dextromethorphan
• known acute angle-closure glaucoma
• elevated prothrombin time as determined by Prothrombin time (INR) > 1.3
• intake of drugs with a long half-life (greater than 24 hrs) (less than one month prior to administration or during the trial)
• use of any drugs which might influence the results of the trial (less than 10 days prior to study drug administration or expected during the trial)
• use of chewing tobacco or nicotine replacement devices within 6 months before the screening visit
• participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• alcohol abuse (more than 60 g of ethanol per day)
• blood donation or loss greater than 100 mL (less than one month prior to administration or expected during the trial)
• clinically relevant laboratory abnormalities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1206.10

Identifier Type: -

Identifier Source: org_study_id