Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Midazolam in Healthy Male Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of the study was to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for CYP3A4. The PK of midazolam was measured before dosing of BIRT 2584 XX, after a single dose of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Healthy male subjects as determined by results of the screening

• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

• Age ≥ 18 and ≤ 55 years

• BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

• Any finding during the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological, or hormonal disorders

• Surgery of gastrointestinal tract (except appendectomy)

• Diseases of the central nervous system (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

• Intake of drugs with a long half-life (greater than 24 hours) (less than 1 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)

• Participation in another trial with an investigational drug (less than 2 months prior to administration or expected during trial)

• Smoker (more than 10 cigarettes/day or more than 3 cigars/day or more than 3 pipes/day)

• Alcohol abuse (more than 60 g of ethanol per day)

• Drug abuse

• Blood donation or loss greater than 400 mL (less than 1 month prior to administration or expected during the trial)

• Clinically relevant laboratory abnormalities