COPDPhase 1NCT02119247
Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or the Capsule for Oral Inhalation Via Aerolizer® Device
A Phase 1 study testing CHF 6001 dry powder for inhalation via NEXThaler® and CHF 6001 DPI capsules for inhalation via Aerolizer in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
Trial summary
The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- CHF 6001 dry powder for inhalation via NEXThaler® and CHF 6001 DPI capsules for inhalation via Aerolizer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Jun 2014
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject's written informed consent obtained prior to any study-related procedure
- Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly
- Able to generate sufficient PIF
- Male and female subjects aged 18 to 55 years inclusive
- Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive
- Non- or ex-smokers who smoked < 5 pack years
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- Good physical and mental status
- Lung function within normal limits
- Results of laboratory tests within the normal ranges
- adequate contraception
Who cannot join
- Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication
- Pregnant or lactating women
- Positive HIV1 or HIV2 serology
- Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C
- Unsuitable veins for repeated venipuncture
- History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen
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- Subjects who have a positive urine test for cotinine at screening or at randomization
- Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation
- Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
- Subjects who have clinically significant cardiovascular condition according to investigator's judgment
- An abnormal 12-lead ECG
- Subjects whose electrocardiogram (12-lead ECG) shows QTcF > 450 ms for males or QTcF > 470 ms for females
- Diastolic Blood Pressure > 90 mmHg and/or Systolic Blood Pressure > 140 mmHg
- Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening
- History of hypersensitivity to any of the excipients contained in the formulations used in the trial
- Any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, taken in the 14 days (2 months for enzyme-inducing or enzyme-inhibiting drugs e.g., glucocorticoids, phenobarbital) before the screening visit and likely to receive these treatments until the end of the study procedures with the exception of occasional paracetamol (maximum 2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions), hormonal contraceptives and hormonal replacement treatment for post-menopausal women
- Treatment within the previous 3 months before the screening visit and likely to receive these treatments until the end of the study procedures in the last treatment period with biologic drugs and with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole)
- Subjects who refuse to respect the required study restrictions related to alcohol, xanthine, grapefruit, food and water intake and strenuous activities
- Heavy caffeine drinker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, SINGLE DOSE STUDY IN HEALTHY VOLUNTEERS TO INVESTIGATE THE PHARMACOKINETICS OF CHF 6001 DPI ADMINISTERED USING THE MULTI-DOSE RESERVOIR NEXThaler® DEVICE OR THE CAPSULE FOR ORAL INHALATION VIA AEROLIZER® DEVICE
The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®.
CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an inhaler device. Previous studies were conducted using a single-dose capsule inhaler (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler® device will be used.
Read the detailed description
This is an Open-label, randomized, 2-way cross-over, Phase I study. The study is conducted in 1 single european site. The main scope of the study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 DPI administered using the multi-dose reservoir NEXThaler® device or the single-dose capsule Aerolizer® device.
- Conditions
- COPD
- Being tested
- CHF 6001 dry powder for inhalation via NEXThaler®, CHF 6001 DPI capsules for inhalation via Aerolizer
- Keywords
- systemic availability , pharmacokinetics, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 6001 dry powder for inhalation via NEXThaler®Device
CHF 6001 DPI capsules for inhalation via AerolizerDevice
| Study group | Role | What they receive |
|---|---|---|
| CHF6001 dry powder for inhalation via NEXThaler® | Experimental | 4 inhalations of CHF 6001 NEXThaler® Receives: Device: CHF 6001 dry powder for inhalation via NEXThaler® |
| CHF 6001 DPI capsules for inhalation via Aerolizer | Active comparator | 3 inhalations of CHF 6001 capsules via Aerolizer® Receives: Device: CHF 6001 DPI capsules for inhalation via Aerolizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve of CHF 6001
CHF 6001 AUC0-t (area under the plasma concentration-time curve from time 0 to the last quantifiable concentration) and Cmax (maximum plasma concentration).
Measured: 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at Period 1 and Period 2
Secondary outcomes (1)
Other pharmacokinetic parameters for CHF 6001 and metabolites in plasma
CHF 6001 AUC0-2h, AUC0-96h, AUC0-∞, tmax (time to Cmax), t½ (terminal elimination half-life ), CHF 5956 and CHF 6095 AUC0-t, Cmax, AUC0-2h, AUC0-96h, AUC0-∞, tmax, t½.
Measured: pre-dose, 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at period 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Leempoels, MD, Principal investigator, SGS CPU Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119247
- Sponsor's protocol ID
- CCD-06001AA1-07
- Other IDs
- 2013-005490-41
- Status last verified
- Jul 2014
- First submitted
- 7 Apr 2014
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, SINGLE DOSE STUDY IN HEALTHY VOLUNTEERS TO INVESTIGATE THE PHARMACOKINETICS OF CHF 6001 DPI ADMINISTERED USING THE MULTI-DOSE RESERVOIR NEXThaler® DEVICE OR THE CAPSULE FOR ORAL INHALATION VIA AEROLIZER® DEVICE
- ClinicalTrials.gov ID
- NCT02119247
- Acronym / sponsor ID
- CCD-06001AA1-07
- Conditions
- COPD
- Keywords
- systemic availability , pharmacokinetics, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Apr 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.
The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®.
CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an inhaler device. Previous studies were conducted using a single-dose capsule inhaler (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler® device will be used.
Detailed description
This is an Open-label, randomized, 2-way cross-over, Phase I study. The study is conducted in 1 single european site. The main scope of the study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 DPI administered using the multi-dose reservoir NEXThaler® device or the single-dose capsule Aerolizer® device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF6001 dry powder for inhalation via NEXThaler® | Experimental | Device: CHF 6001 dry powder for inhalation via NEXThaler®4 inhalations of CHF 6001 NEXThaler® |
| CHF 6001 DPI capsules for inhalation via Aerolizer | Active comparator | Device: CHF 6001 DPI capsules for inhalation via Aerolizer3 inhalations of CHF 6001 capsules via Aerolizer® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject's written informed consent obtained prior to any study-related procedure
- Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly
- Able to generate sufficient PIF
- Male and female subjects aged 18 to 55 years inclusive
- Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive
Key exclusion criteria (19 listed)
- Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication
- Pregnant or lactating women
- Positive HIV1 or HIV2 serology
- Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C
- Unsuitable veins for repeated venipuncture
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 |
|---|---|---|
| CHF 6001 dry powder for inhalation via NEXThaler® | Device | CHF6001 dry powder for inhalation via NEXThaler® |
| CHF 6001 DPI capsules for inhalation via Aerolizer | Device | CHF 6001 DPI capsules for inhalation via Aerolizer |
Primary outcome
Area under the plasma concentration-time curve of CHF 6001
Time frame: 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at Period 1 and Period 2
CHF 6001 AUC0-t (area under the plasma concentration-time curve from time 0 to the last quantifiable concentration) and Cmax (maximum plasma concentration).
1 secondary outcome
Other pharmacokinetic parameters for CHF 6001 and metabolites in plasma
Time frame: pre-dose, 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at period 1 and 2
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 1 Aug 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.
Joe Leempoels, MD principal investigator
SGS CPU Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHF 6001 dry powder for inhalation via NEXThaler® and CHF 6001 DPI capsules for inhalation via Aerolizer in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
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 10 inclusion and 19 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 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Area under the plasma concentration-time curve of CHF 6001 (time frame: 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at Period 1 and Period 2). 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 1 Aug 2014.