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

NCT02269189 | Completed Phase 1

• 1 other identifier: 543.37
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (7)

• Changes from baseline in physical examination

  Pre-dose and 72 hours after last drug administration

• Number of patients with clinically relevant findings in vital signs

  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

  Pre-dose, up to 72 hours after last drug administration

• Number of patients with clinically relevant changes in oximetry

  Pre-dose, up to 72 hours after last drug administration

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

  Pre-dose, up to 72 hours after last drug administration

• Number of patients with clinically relevant findings in laboratory evaluation

  Up to 72 hours after last drug administration

• Number of patients with adverse events

  Up to 72 hours after last drug administration

Secondary Outcomes (11)

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

  Up to 72 hours after last drug administration

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

  Up to 72 hours after last drug administration

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

  Up to 72 hours after last drug administration

• Concentration of the analyte in plasma after 24 hours (C24h)

  24 hours after drug administration

• Pre-dose concentration of the analyte in plasma immediately before administration of the next dose (Cpre)

  Up to day 16

Study Arms (3)

BIIL 284 BS, high dose in adult patients

EXPERIMENTAL

Drug: BIIL 284 BS, high dose

BIIL 284 BS, low dose in pediatric patients

EXPERIMENTAL

Drug: BIIL 284 BS, low dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIL 284 BS, high dose DRUG

BIIL 284 BS, high dose in adult patients

BIIL 284 BS, low dose DRUG

BIIL 284 BS, low dose in pediatric 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:

• 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

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 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.

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 16, 2014
• First Posted: October 21, 2014
• Study Start: April 1, 2002
• Primary Completion: November 1, 2002
• Last Updated: October 21, 2014

Record last verified: 2014-10