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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Midazolam

Drug: BIRT 2584 XX

Study type

Interventional

Funder types

Industry

Identifiers

NCT02256748

1206.9

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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