Cystic FibrosisPhase 1NCT02269189
Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients
A Phase 1 study testing BIIL 284 BS, high dose and BIIL 284 BS, low dose in people with Cystic Fibrosis, run by Boehringer Ingelheim.
Trial summary
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing) 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, high dose and BIIL 284 BS, low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Nov 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
- 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
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 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
Show all 12Show fewer
- 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.
About this study
Official title: A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeated Oral Doses (15-day Dosing) of BIIL 284 BS in Adult (300 mg) and Pediatric (150 mg) Cystic Fibrosis Patients
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)
- Conditions
- Cystic Fibrosis
- Being tested
- BIIL 284 BS, high dose, BIIL 284 BS, low dose, Placebo
- 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, high doseDrug
BIIL 284 BS, low doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIL 284 BS, high dose in adult patients | Experimental | Not described Receives: Drug: BIIL 284 BS, high dose |
| BIIL 284 BS, low dose in pediatric patients | Experimental | Not described Receives: Drug: BIIL 284 BS, low dose |
| 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 72 hours after last drug administration
Number of patients with clinically relevant findings in vital signs
blood pressure, pulse rate, respiratory rate, body temperature
Measured: Up to 72 hours after last drug administration
Number of patients with clinically relevant changes in spirometry
Measured: Pre-dose, up to 72 hours after last drug administration
Number of patients with clinically relevant changes in oximetry
Measured: Pre-dose, up to 72 hours after last drug administration
Number of patients with clinically relevant changes in 12-lead ECG
Measured: Pre-dose, up to 72 hours after last drug administration
Number of patients with clinically relevant findings in laboratory evaluation
Measured: Up to 72 hours after last drug administration
Number of patients with adverse events
Measured: Up to 72 hours after last drug administration
Secondary outcomes (11)
Area under the concentration-time curve of the analyte in plasma (AUC)
Measured: Up to 72 hours after last drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 72 hours after last drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: Up to 72 hours after last drug administration
Concentration of the analyte in plasma after 24 hours (C24h)
Measured: 24 hours after drug administration
Pre-dose concentration of the analyte in plasma immediately before administration of the next dose (Cpre)
Measured: Up to day 16
Terminal rate constant of the analyte in plasma (λz)
Measured: Up to 72 hours after last drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: Up to 72 hours after last drug administration
Mean residence time of the analyte in the body at steady state (MRTss)
Measured: Up to 72 hours after last drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration at steady state (Vz,ss/F)
Measured: Up to 72 hours after last drug administration
Accumulation ratio for AUC after the 15th dose over the dosing interval compared to the first dose (RA,AUC)
Measured: day 1, day 15
Accumulation ratio for Cmax after the 15th dose over the dosing interval compared to the first dose (RA,Cmax)
Measured: day 1, day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startApr 2002
- Primary completionNov 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269189
- Sponsor's protocol ID
- 543.37
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 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 Repeated Oral Doses (15-day Dosing) of BIIL 284 BS in Adult (300 mg) and Pediatric (150 mg) Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT02269189
- Acronym / sponsor ID
- 543.37
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Nov 2002 (actual)
- First posted
- 21 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 repeated doses (15-day dosing)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 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 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
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, 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 |
Primary outcome
Changes from baseline in physical examination
Time frame: Pre-dose and 72 hours after last drug administration
Number of patients with clinically relevant findings in vital signs
Time frame: Up to 72 hours after last drug administration
blood pressure, pulse rate, respiratory rate, body temperature
Number of patients with clinically relevant changes in spirometry
Time frame: Pre-dose, up to 72 hours after last drug administration
Number of patients with clinically relevant changes in oximetry
Time frame: Pre-dose, up to 72 hours after last drug administration
Number of patients with clinically relevant changes in 12-lead ECG
Time frame: Pre-dose, up to 72 hours after last drug administration
Number of patients with clinically relevant findings in laboratory evaluation
Time frame: Up to 72 hours after last drug administration
Number of patients with adverse events
Time frame: Up to 72 hours after last drug administration
11 secondary outcomes
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: Up to 72 hours after last drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 72 hours after last drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 72 hours after last drug administration
Concentration of the analyte in plasma after 24 hours (C24h)
Time frame: 24 hours after drug administration
Pre-dose concentration of the analyte in plasma immediately before administration of the next dose (Cpre)
Time frame: Up to day 16
Terminal rate constant of the analyte in plasma (λz)
Time frame: Up to 72 hours after last drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 72 hours after last drug administration
Mean residence time of the analyte in the body at steady state (MRTss)
Time frame: Up to 72 hours after last drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration at steady state (Vz,ss/F)
Time frame: Up to 72 hours after last drug administration
Accumulation ratio for AUC after the 15th dose over the dosing interval compared to the first dose (RA,AUC)
Time frame: day 1, day 15
Accumulation ratio for Cmax after the 15th dose over the dosing interval compared to the first dose (RA,Cmax)
Time frame: day 1, day 15
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 21 Oct 2014.
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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?
A Phase 1 study testing BIIL 284 BS, high dose and BIIL 284 BS, low dose in people with Cystic Fibrosis, run by Boehringer Ingelheim.
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 8 inclusion and 12 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 21 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 72 hours after last 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?
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 21 Oct 2014.