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

NCT02265679 | Completed Phase 1

• 1 other identifier: 543.36
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety, tolerability and pharmacokinetics following single doses

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (7)

• Changes from baseline in physical examination

  Pre-dose and up to 5 days after drug administration

• Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate, respiratory rate, body temperature)

  Pre-dose, up to 5 days after drug administration

• Changes from baseline in spirometry

  Pre-dose and up to 5 days after drug administration

• Changes from baseline in oximetry

  Pre-dose and up to 5 days after drug administration

• Number of patients with clinically relevant changes in 12-lead ECG

  Pre-dose, up to 5 days after drug administration

• Number of patients with clinically relevant changes in laboratory evaluation

  Pre-dose, up to 5 days after drug administration

• Number of patients with adverse events

  Up to 5 days after drug administration

Secondary Outcomes (10)

• Plasma concentration-time profiles of BIIL 315 ZW in all dose groups

  Up to 5 days after drug administration

• Plasma concentration-time profiles of BIIL 284 BS, BIIL 260 BS and BIIL 304 ZW in medium dose adult and high dose pediatric group

  Up to 5 days after drug administration

• Area under the concentration-time curve of the analytes in plasma (AUC)

  Up to 5 days after drug administration

• Maximum measured concentration of the analytes in plasma (Cmax)

  Up to 5 days after drug administration

• Time from dosing to the maximum concentration of the analytes in plasma (tmax)

  Up to 5 days after drug administration

Study Arms (7)

BIIL 284 BS, low dose in pediatric patients

EXPERIMENTAL

Drug: BIIL 284 BS, low dose, pediatric patients

BIIL 284 BS, medium dose in pediatric patients

EXPERIMENTAL

Drug: BIIL 284 BS, medium dose, pediatric patients

BIIL 284 BS, high dose in pediatric patients

EXPERIMENTAL

Drug: BIIL 284 BS, high dose, pediatric patients

BIIL 284 BS, low dose in adult patients

EXPERIMENTAL

Drug: BIIL 284 BS, low dose, adult patients

BIIL 284 BS, medium dose in adult patients

EXPERIMENTAL

Drug: BIIL 284 BS, medium dose, adult patients

BIIL 284 BS, high dose in adult patients

EXPERIMENTAL

Drug: BIIL 284 BS, high dose, adult patients

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIL 284 BS, low dose, pediatric patients DRUG

BIIL 284 BS, low dose in pediatric patients

BIIL 284 BS, medium dose, pediatric patients DRUG

BIIL 284 BS, medium dose in pediatric patients

BIIL 284 BS, high dose, pediatric patients DRUG

BIIL 284 BS, high dose in pediatric patients

BIIL 284 BS, low dose, adult patients DRUG

BIIL 284 BS, low dose in adult patients

BIIL 284 BS, medium dose, adult patients DRUG

BIIL 284 BS, medium dose in adult patients

BIIL 284 BS, high dose, adult patients DRUG

BIIL 284 BS, high dose in adult patients

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

amelubant

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

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

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 16, 2014
• Study Start: October 1, 2001
• Primary Completion: July 1, 2002
• Last Updated: October 16, 2014

Record last verified: 2014-10