Cystic FibrosisPhase 1NCT02265679

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

A Phase 1 study testing BIIL 284 BS, low dose, pediatric patients, BIIL 284 BS, medium dose, pediatric patients and BIIL 284 BS, high dose, pediatric patients in people with Cystic Fibrosis, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Safety, tolerability and pharmacokinetics following single doses Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Cystic Fibrosis
What is being tested?: BIIL 284 BS, low dose, pediatric patients, BIIL 284 BS, medium dose, pediatric patients and BIIL 284 BS, high dose, pediatric patients
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: No sites listed yet
Study dates: Oct 2001to Jul 2002
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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.

About this study

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

Safety, tolerability and pharmacokinetics following single doses

Conditions: Cystic Fibrosis
Being tested: 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
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIIL 284 BS, low dose, pediatric patientsDrug
BIIL 284 BS, medium dose, pediatric patientsDrug
BIIL 284 BS, high dose, pediatric patientsDrug
BIIL 284 BS, low dose, adult patientsDrug
BIIL 284 BS, medium dose, adult patientsDrug
BIIL 284 BS, high dose, adult patientsDrug
PlaceboDrug

Study groups in NCT02265679
Study group	Role	What they receive
BIIL 284 BS, low dose in pediatric patients	Experimental	Not described Receives: Drug: BIIL 284 BS, low dose, pediatric patients
BIIL 284 BS, medium dose in pediatric patients	Experimental	Not described Receives: Drug: BIIL 284 BS, medium dose, pediatric patients
BIIL 284 BS, high dose in pediatric patients	Experimental	Not described Receives: Drug: BIIL 284 BS, high dose, pediatric patients
BIIL 284 BS, low dose in adult patients	Experimental	Not described Receives: Drug: BIIL 284 BS, low dose, adult patients
BIIL 284 BS, medium dose in adult patients	Experimental	Not described Receives: Drug: BIIL 284 BS, medium dose, adult patients
BIIL 284 BS, high dose in adult patients	Experimental	Not described Receives: Drug: BIIL 284 BS, high dose, adult patients
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes from baseline in physical examination
Measured: 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)
Measured: Pre-dose, up to 5 days after drug administration
Changes from baseline in spirometry
Measured: Pre-dose and up to 5 days after drug administration
Changes from baseline in oximetry
Measured: Pre-dose and up to 5 days after drug administration
Number of patients with clinically relevant changes in 12-lead ECG
Measured: Pre-dose, up to 5 days after drug administration
Number of patients with clinically relevant changes in laboratory evaluation
Measured: Pre-dose, up to 5 days after drug administration
Number of patients with adverse events
Measured: Up to 5 days after drug administration

Secondary outcomes (10)

Plasma concentration-time profiles of BIIL 315 ZW in all dose groups
Measured: 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
Measured: Up to 5 days after drug administration
Area under the concentration-time curve of the analytes in plasma (AUC)
Measured: Up to 5 days after drug administration
Maximum measured concentration of the analytes in plasma (Cmax)
Measured: Up to 5 days after drug administration
Time from dosing to the maximum concentration of the analytes in plasma (tmax)
Measured: Up to 5 days after drug administration
Terminal half-life of the analytes in plasma (t1/2)
Measured: Up to 5 days after drug administration
Total mean residence time of the analytes in the body (MRTtot)
Measured: Up to 5 days after drug administration
Terminal rate constant of the analytes in plasma (λz)
Measured: Up to 5 days after drug administration
Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
Measured: Up to 5 days after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Measured: Up to 5 days after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2001Jul 2002

First posted16 Oct 2014 (estimated)
Study startOct 2001
Primary completionJul 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02265679
Sponsor's protocol ID: 543.36
Status last verified: Oct 2014
First submitted: 15 Oct 2014
Last updated: 16 Oct 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02265679
Acronym / sponsor ID: 543.36
Conditions: Cystic Fibrosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2001
Primary completion: Jul 2002 (actual)
First posted: 16 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Safety, tolerability and pharmacokinetics following single doses

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 7

Arm	Type	Receives
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

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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

Primary outcome

Changes from baseline in physical examination
Time frame: 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)
Time frame: Pre-dose, up to 5 days after drug administration
Changes from baseline in spirometry
Time frame: Pre-dose and up to 5 days after drug administration
Changes from baseline in oximetry
Time frame: Pre-dose and up to 5 days after drug administration
Number of patients with clinically relevant changes in 12-lead ECG
Time frame: Pre-dose, up to 5 days after drug administration
Number of patients with clinically relevant changes in laboratory evaluation
Time frame: Pre-dose, up to 5 days after drug administration
Number of patients with adverse events
Time frame: Up to 5 days after drug administration

10 secondary outcomes

Plasma concentration-time profiles of BIIL 315 ZW in all dose groups
Time frame: 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
Time frame: Up to 5 days after drug administration
Area under the concentration-time curve of the analytes in plasma (AUC)
Time frame: Up to 5 days after drug administration
Maximum measured concentration of the analytes in plasma (Cmax)
Time frame: Up to 5 days after drug administration
Time from dosing to the maximum concentration of the analytes in plasma (tmax)
Time frame: Up to 5 days after drug administration
Terminal half-life of the analytes in plasma (t1/2)
Time frame: Up to 5 days after drug administration
Total mean residence time of the analytes in the body (MRTtot)
Time frame: Up to 5 days after drug administration
Terminal rate constant of the analytes in plasma (λz)
Time frame: Up to 5 days after drug administration
Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
Time frame: Up to 5 days after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Time frame: Up to 5 days after drug administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.

Related trials for Cystic Fibrosis

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Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in physical examination (time frame: Pre-dose and up to 5 days after drug administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02265679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.