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

Cystic Fibrosis Clinical Trial

Official title:

A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265679
• Other study ID #: 543.36
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2014
• Last updated: October 15, 2014
• Start date: October 2001

Study information

• Verified date: October 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety, tolerability and pharmacokinetics following single doses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• BIIL 284 BS, low dose, pediatric patients

• BIIL 284 BS, medium dose, pediatric patients

• BIIL 284 BS, high dose, pediatric patients

• BIIL 284 BS, low dose, adult patients

• BIIL 284 BS, medium dose, adult patients

• BIIL 284 BS, high dose, adult patients

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in physical examination		Pre-dose and up to 5 days after drug administration	No
Primary	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	No
Primary	Changes from baseline in spirometry		Pre-dose and up to 5 days after drug administration	No
Primary	Changes from baseline in oximetry		Pre-dose and up to 5 days after drug administration	No
Primary	Number of patients with clinically relevant changes in 12-lead ECG		Pre-dose, up to 5 days after drug administration	No
Primary	Number of patients with clinically relevant changes in laboratory evaluation		Pre-dose, up to 5 days after drug administration	No
Primary	Number of patients with adverse events		Up to 5 days after drug administration	No
Secondary	Plasma concentration-time profiles of BIIL 315 ZW in all dose groups		Up to 5 days after drug administration	No
Secondary	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	No
Secondary	Area under the concentration-time curve of the analytes in plasma (AUC)		Up to 5 days after drug administration	No
Secondary	Maximum measured concentration of the analytes in plasma (Cmax)		Up to 5 days after drug administration	No
Secondary	Time from dosing to the maximum concentration of the analytes in plasma (tmax)		Up to 5 days after drug administration	No
Secondary	Terminal half-life of the analytes in plasma (t1/2)		Up to 5 days after drug administration	No
Secondary	Total mean residence time of the analytes in the body (MRTtot)		Up to 5 days after drug administration	No
Secondary	Terminal rate constant of the analytes in plasma (?z)		Up to 5 days after drug administration	No
Secondary	Apparent clearance of the analytes in plasma following extravascular administration (CL/F)		Up to 5 days after drug administration	No
Secondary	Apparent volume of distribution during the terminal phase ?z following extravascular administration (Vz/F)		Up to 5 days after drug administration	No

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