- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02269189
Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients
October 20, 2014 updated by: Boehringer Ingelheim
A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeated Oral Doses (15-day Dosing) of BIIL 284 BS in Adult (300 mg) and Pediatric (150 mg) Cystic Fibrosis Patients
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female ≥ 6 years (pediatric 6 - 17 years inclusive; adult ≥ 18 years); minimum weight requirement of 20 kg
- Confirmed diagnosis of CF (positive sweat chloride ≥ 60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype
- Forced expiratory volume in one second (FEV1) > 25% predicted (using prediction equation's of Knudson et al)
- Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within 2 weeks of screening
- Females of child bearing potential must have a negative pregnancy test at screening and, if sexually active, must be willing to use a double-barrier form of contraception for the duration of the study
- The patient or the patient's legally acceptable representative must be able to give informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation
- The patient must be able to swallow the BIIL 284 tablet whole
- Patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study
Exclusion Criteria:
- Patients with a history of allergy/hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the Investigator
- Patients who have participated in another study with an investigational drug (including BI Trial 543.36) within one month or 6 half-lives (whichever is greater) preceding the screening visit
- Patients with known substance abuse, including alcohol or drug abuse, within 30 days prior to screening
- Female patients who are pregnant or lactating
- Patients who are unable to comply with breakfast requirements prior to dosing
- Patients who have received IV, oral or inhaled antibiotics or corticosteroids for a pulmonary exacerbation within 2 weeks of screening
- Patients who have started a new chronic medication for CF within 2 weeks of screening
- Patients with documented persistent colonization with B. cepacia (defined as more than one positive culture within the past year)
- Patients with clinically significant findings on chest x-ray which in the opinion of the Investigator precludes the patient's participation in the trial
- Patients with oxyhemoglobin saturation in room air < 90% by pulse oximetry
- Patients with hemoglobin < 9.0 g/dL; platelets < 100x10**9/L; prothrombin time (PT) > 1.5 times the upper limit of normal, serum glutamic-oxaloacetic transaminase (ALT) or serum glutamic-pyruvic transaminase (AST) > 2 times the upper limit of normal; creatinine > 1.8 mg/dL (adults) or > 1.4 mg/dL (pediatrics) at screening
- Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This includes significant hematological, hepatic, renal, cardiovascular, and neurologic disease. Patients with diabetes may participate if their disease is under good control prior to screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: BIIL 284 BS, low dose in pediatric patients
|
|
Experimental: BIIL 284 BS, high dose in adult patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in physical examination
Time Frame: Pre-dose and 72 hours after last drug administration
|
Pre-dose and 72 hours after last drug administration
|
|
Number of patients with clinically relevant findings in vital signs
Time Frame: Up to 72 hours after last drug administration
|
blood pressure, pulse rate, respiratory rate, body temperature
|
Up to 72 hours after last drug administration
|
Number of patients with clinically relevant changes in spirometry
Time Frame: Pre-dose, up to 72 hours after last drug administration
|
Pre-dose, up to 72 hours after last drug administration
|
|
Number of patients with clinically relevant changes in oximetry
Time Frame: Pre-dose, up to 72 hours after last drug administration
|
Pre-dose, up to 72 hours after last drug administration
|
|
Number of patients with clinically relevant changes in 12-lead ECG
Time Frame: Pre-dose, up to 72 hours after last drug administration
|
Pre-dose, up to 72 hours after last drug administration
|
|
Number of patients with clinically relevant findings in laboratory evaluation
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
|
Number of patients with adverse events
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analyte in plasma (AUC)
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
Concentration of the analyte in plasma after 24 hours (C24h)
Time Frame: 24 hours after drug administration
|
24 hours after drug administration
|
Pre-dose concentration of the analyte in plasma immediately before administration of the next dose (Cpre)
Time Frame: Up to day 16
|
Up to day 16
|
Terminal rate constant of the analyte in plasma (λz)
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
Terminal half-life of the analyte in plasma (t1/2)
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
Mean residence time of the analyte in the body at steady state (MRTss)
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
Apparent volume of distribution during the terminal phase λz following extravascular administration at steady state (Vz,ss/F)
Time Frame: Up to 72 hours after last drug administration
|
Up to 72 hours after last drug administration
|
Accumulation ratio for AUC after the 15th dose over the dosing interval compared to the first dose (RA,AUC)
Time Frame: day 1, day 15
|
day 1, day 15
|
Accumulation ratio for Cmax after the 15th dose over the dosing interval compared to the first dose (RA,Cmax)
Time Frame: day 1, day 15
|
day 1, day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Primary Completion (Actual)
November 1, 2002
Study Registration Dates
First Submitted
October 16, 2014
First Submitted That Met QC Criteria
October 20, 2014
First Posted (Estimate)
October 21, 2014
Study Record Updates
Last Update Posted (Estimate)
October 21, 2014
Last Update Submitted That Met QC Criteria
October 20, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 543.37
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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