Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients

NCT ID: NCT02265679

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

Brief Summary

Safety, tolerability and pharmacokinetics following single doses

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIIL 284 BS, low dose in pediatric patients

Group Type: EXPERIMENTAL

BIIL 284 BS, low dose, pediatric patients

Intervention Type: DRUG

BIIL 284 BS, medium dose in pediatric patients

Group Type: EXPERIMENTAL

BIIL 284 BS, medium dose, pediatric patients

Intervention Type: DRUG

BIIL 284 BS, high dose in pediatric patients

Group Type: EXPERIMENTAL

BIIL 284 BS, high dose, pediatric patients

Intervention Type: DRUG

BIIL 284 BS, low dose in adult patients

Group Type: EXPERIMENTAL

BIIL 284 BS, low dose, adult patients

Intervention Type: DRUG

BIIL 284 BS, medium dose in adult patients

Group Type: EXPERIMENTAL

BIIL 284 BS, medium dose, adult patients

Intervention Type: DRUG

BIIL 284 BS, high dose in adult patients

Group Type: EXPERIMENTAL

BIIL 284 BS, high dose, adult patients

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BIIL 284 BS, low dose, pediatric patients

Intervention Type: DRUG

BIIL 284 BS, medium dose, pediatric patients

Intervention Type: DRUG

BIIL 284 BS, high dose, pediatric patients

Intervention Type: DRUG

BIIL 284 BS, low dose, adult patients

Intervention Type: DRUG

BIIL 284 BS, medium dose, adult patients

Intervention Type: DRUG

BIIL 284 BS, high dose, adult patients

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All participants in the study were cystic fibrosis patients:
• Male or female ≥6 years (pediatrics 6 - 17 years; 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)
• 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 needed to have a negative pregnancy test at screening and, if sexually active, had to 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 had to be able to give informed consent in accordance with international conference of harmonization (ICH) good clinical practice (GCP) guidelines and local legislation
• The patient must be able to swallow the BIIL 284 BS 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 had participated in another study with an investigational drug 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
• Patients who participated in excessive physical activities (e.g. strenuous sporting events) within 24 hours before the study
• Female patients who were pregnant or lactating
• Patients who were unable to comply with breakfast requirements prior to dosing
• Patients who had received IV, oral or inhaled antibiotics or corticosteroids for a pulmonary exacerbation within 2 weeks of screening
• Patients who had 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 <100x109/L; serum glutamic-oxaloacetic transaminase (ALT) or serum glutamic-pyruvic transaminase (AST) >2 times the upper limit of normal; creatinine >1.8 mg/dL 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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

543.36

Identifier Type: -

Identifier Source: org_study_id