Effect of BIIL 284 BS on the Pharmacokinetics of Theophylline in Healthy Male Volunteers

NCT02273440 | Completed Phase 1

• 1 other identifier: 543.7
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Plasma levels of theophylline

  up to 72 hours after theophylline administration

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

  up to 72 hours after theophylline administration

• Peak plasma concentration (Cmax) for theophylline

  up to 72 hours after theophylline administration

Secondary Outcomes (11)

• Time to peak plasma concentration (tmax)

  up to 72 hours after theophylline administration

• Terminal half-life (t1/2)

  up to 72 hours after theophylline administration

• Total mean residence time (MRTtot)

  up to 72 hours after theophylline administration

• Total clearance after oral administration (CLtot/F)

  up to 72 hours after theophylline administration

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

  up to 72 hours after theophylline administration

Study Arms (2)

BIIL 284 BS with theophylline

EXPERIMENTAL

Drug: BIIL 284 BS; Drug: Theophylline

Placebo with theophylline

PLACEBO COMPARATOR

Drug: Theophylline; Drug: Placebo

Interventions

BIIL 284 BS DRUG

BIIL 284 BS with theophylline

Theophylline DRUG

BIIL 284 BS with theophylline; Placebo with theophylline

Placebo DRUG

Placebo with theophylline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

amelubant; Theophylline

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 24, 2014
• Study Start: May 1, 2000
• Primary Completion: July 1, 2000
• Last Updated: October 24, 2014

Record last verified: 2014-10