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

Boehringer Ingelheim

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Digoxin; Drug: Warfarin; Drug: BI 1181181; Drug: Midazolam; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02345304

1344.3

2014-004329-42 (EudraCT Number)

Details and patient eligibility

About

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)

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 5 patient groups

Treatment 3

Experimental group

Description:

single dose of midazolam + BI drug

Treatment:

Drug: BI 1181181

Drug: BI 1181181

Drug: Midazolam

Drug: BI 1181181

Drug: Midazolam

Drug: Midazolam

Treatment 4

Experimental group

Description:

single dose of probe drugs + BI drug

Treatment:

Drug: BI 1181181

Drug: BI 1181181

Drug: Midazolam

Drug: Warfarin

Drug: BI 1181181

Drug: Warfarin

Drug: Midazolam

Drug: Omeprazole

Drug: Midazolam

Drug: Omeprazole

Treatment 5

Experimental group

Description:

single dose of digoxin + BI drug

Treatment:

Drug: BI 1181181

Drug: BI 1181181

Drug: Digoxin

Drug: Digoxin

Drug: BI 1181181

Treatment 1

Experimental group

Description:

single doses of probe drugs

Treatment:

Drug: Midazolam

Drug: Warfarin

Drug: Warfarin

Drug: Midazolam

Drug: Omeprazole

Drug: Midazolam

Drug: Omeprazole

Treatment 2

Experimental group

Description:

single dose of digoxin

Treatment:

Drug: Digoxin

Drug: Digoxin