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

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ClinicalTrials.gov Identifier: NCT02273440
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIL 284 BS Drug: Theophylline Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : May 2000
Actual Primary Completion Date : July 2000

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIIL 284 BS with theophylline Drug: BIIL 284 BS
Drug: Theophylline
Placebo Comparator: Placebo with theophylline Drug: Theophylline
Drug: Placebo



Primary Outcome Measures :
  1. Plasma levels of theophylline [ Time Frame: up to 72 hours after theophylline administration ]
  2. Area under the curve from zero extrapolated to infinity (AUC0-infinity) [ Time Frame: up to 72 hours after theophylline administration ]
  3. Peak plasma concentration (Cmax) for theophylline [ Time Frame: up to 72 hours after theophylline administration ]

Secondary Outcome Measures :
  1. Time to peak plasma concentration (tmax) [ Time Frame: up to 72 hours after theophylline administration ]
  2. Terminal half-life (t1/2) [ Time Frame: up to 72 hours after theophylline administration ]
  3. Total mean residence time (MRTtot) [ Time Frame: up to 72 hours after theophylline administration ]
  4. Total clearance after oral administration (CLtot/F) [ Time Frame: up to 72 hours after theophylline administration ]
  5. Volume of distribution during terminal phase after oral administration (Vz/F) [ Time Frame: up to 72 hours after theophylline administration ]
  6. Area under the concentration time curve at steady state (AUC,ss) for BIIL 315 ZW [ Time Frame: up to 72 hours after theophylline administration ]
  7. Peak plasma concentration at steady state (Cmax,ss) for BIIL 315 ZW [ Time Frame: up to 72 hours after theophylline administration ]
  8. Number of patients with adverse events [ Time Frame: up to 5 days after last theophylline administration ]
  9. Number of patients with clinically significant findings in vital signs [ Time Frame: up to 3 days after last drug administration ]
  10. Number of patients with clinically significant findings in laboratory tests [ Time Frame: up to 3 days after last drug administration ]
  11. Number of patients with clinically significant findings in 12-lead ECG [ Time Frame: up to 3 days after last drug administration ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273440    
Other Study ID Numbers: 543.7
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents