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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Experimental: BIIL 284 BS, low dose in pediatric patients
Drug: BIIL 284 BS, low dose
Experimental: BIIL 284 BS, high dose in adult patients
Drug: BIIL 284 BS, high dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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