DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: BIRT 2584 XX (Drug); Midazolam (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Clinical Details

Official title: A Study to Evaluate the Effect of Multiple Doses of 500 mg of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Midazolam in Healthy Male Volunteers

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

AUC0-∞ of midazolam (area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity)

Cmax of midazolam (maximum concentration of midazolam in plasma)

AUC0-∞ of 1'-hydroxymidazolam (area under the concentration-time curve of 1'-hydroxymidazolam in plasma over the time interval from 0 extrapolated to infinity)

Cmax of 1'-hydroxymidazolam (maximum concentration of 1'-hydroxymidazolam in plasma)

AUC0-∞ ratio of 1'-hydroxymidazolam to midazolam

Secondary outcome:

AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)

tmax (time from dosing to the maximum concentration of the analytes in plasma)

λz (terminal rate constant of the analytes in plasma)

t1/2 (terminal half-life of the analytes in plasma)

MRTpo (mean residence time of the analytes in the body after po administration)

CL/F (apparent clearance of the analytes in the plasma after extravascular administration)

Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)

Pre-dose levels of BIRT 2584 XX and BI 610100

Number of subjects with abnormal findings in physical examination

Number of subjects with abnormal changes in laboratory parameters

Number of subjects with clinically significant changes in 12-lead ECG

Number of subjects with clinically significant changes in vital signs

Number of subjects with adverse events

Assessment of tolerability by investigator on a 4-point scale

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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

Locations and Contacts

Additional Information

Starting date: June 2005
Last updated: October 2, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017