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

NCT ID: NCT02256748

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30

Brief 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

Conditions

Healthy

Study Design

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

Study Groups

BIRT 2584 XX + Midazolam

BIRT 2584 XX: Multiple doses for 12 days (bid on days 1 and 2, qd from days 3 to 12)

Midazolam: Administration on days -2, 1, 3, and 12

Group Type: EXPERIMENTAL

BIRT 2584 XX

Intervention Type: DRUG

Midazolam

Intervention Type: DRUG

Interventions

BIRT 2584 XX

Intervention Type: DRUG

Midazolam

Intervention Type: DRUG

Eligibility 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

• 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

1206.9

Identifier Type: -

Identifier Source: org_study_id