DrugLib.com — Drug Information Portal

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



Effect of BIIL 284 BS on the Pharmacokinetics of Theophylline 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: BIIL 284 BS (Drug); Theophylline (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

To evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of theophylline.

Clinical Details

Official title: The Effects of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Theophylline in Healthy Male Volunteers (a Randomized, Double-blind, Placebo-controlled, Two-period, Two-way Crossover Study)

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Plasma levels of theophylline

Area under the curve from zero extrapolated to infinity (AUC0-infinity)

Peak plasma concentration (Cmax) for theophylline

Secondary outcome:

Time to peak plasma concentration (tmax)

Terminal half-life (t1/2)

Total mean residence time (MRTtot)

Total clearance after oral administration (CLtot/F)

Volume of distribution during terminal phase after oral administration (Vz/F)

Area under the concentration time curve at steady state (AUC,ss) for BIIL 315 ZW

Peak plasma concentration at steady state (Cmax,ss) for BIIL 315 ZW

Number of patients with adverse events

Number of patients with clinically significant findings in vital signs

Number of patients with clinically significant findings in laboratory tests

Number of patients with clinically significant findings in 12-lead ECG

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Written informed consent signed and dated prior to participation into the study

(including medication washout)

- All volunteers in the study should be healthy males, aged 18-50 years (inclusive) and

willing to use condoms until 60 days after the last dose

- All volunteers should be within +- 20% of their ideal body weight (Metropolitan

Scale, 1983)

- Non-smokers (volunteers who have never smoked) or ex-smokers for at least one year

with a smoking history, no greater than five pack-years (1 pack year = 20 cigarettes per day for one year)

- Ability to comply with the concomitant therapy restrictions

- Volunteers will be off all prescription drugs. O. T.C. drugs must be discontinued for

at least two weeks prior to the first dose of study drug. If throughout the study, volunteers need any O. T.C. medication, the investigator will call the clinical monitor and this will be reviewed on a case-by-case bases. Restrictions for different medications apply

- Volunteers will have no evidence of a clinically relevant concomitant disease based

upon complete medical history, physician global assessment, complete physical examination, ECG, and clinical laboratory tests Exclusion Criteria:

- Viral respiratory tract infection, respiratory tract infection within the six weeks

preceding the first day of dosing with study medication

- Small of difficult to locate arm or hand veins that would impair the clinician's

ability to draw blood samples or to place a venous catheter

- Volunteers with a known drug or alcohol dependence (presence of dependency for 10

years) or who drink more than 60 g of alcohol per day

- History of significant allergic reactions to drugs or sensitivity to aspirin or

positive drug screen

- Use of an investigational new drug in the preceding 3 months or six half-lives

(whichever is greater) prior to the first screen at Visit 1

- Donation of blood during the preceding 3 months of Visit 1

- Volunteers receiving hyposensitization therapy whom are not on a stable dose for the

last three months before Visit 1

- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular,

metabolic, immunological, or hormonal disorders

- Volunteers with disease of the central nervous system (such as epilepsy) or with

psychiatric disorders

- Volunteers with known history of orthostatic hypotension, fainting spells or

blackouts

- Volunteers with chronic or relevant acute infections

- Volunteers with history of allergy/hypersensitivity (including drug allergy) with is

deemed relevant to the trial as judged by the investigator

- Volunteers with eosinophilia > 7%

- Volunteers who received any other drugs which might influence the results of the

trial during the week previous to the start of the study

- Volunteers who participated in excessive physical activities (e. g. competitive

sports) within the last week before the study

Locations and Contacts

Additional Information

Starting date: May 2000
Last updated: October 23, 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