Chronic Obstructive Pulmonary DiseasePhase 1NCT04739774
Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)
A Phase 1 study testing CHF6001 DPI and Itraconazole in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
Trial summary
The objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- CHF6001 DPI and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Feb 2021to 26 Apr 2021
- 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;
- Healthy male and female subjects aged 18-55 years inclusive;
- Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly and to generate sufficient PIF using the In-Check device.
- Body Mass Index (BMI) between 18,0 and 35,0 kg/m2 extremes inclusive;
- Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year prior to screening;
- Good physical and mental status
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- Vital signs within normal limits
- 12 -lead digitalized Electrocardiogram (12-lead ECG) considered as normal
- Pulmonary function test within normal limits
- Women of Childbearing Potential (WOCBP) with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method in addition to a barrier contraception method from the signature of the informed consent and until the follow-up visit. Males with non-pregnant WOCBP partners: they and or/ their partner must be willing to use a highly effective birth control method in addition to the male condom from the signature of the informed consent and until the follow-up visit. Males with pregnant WOCBP partner: they must be willing to use male contraception (condom) from the signature of the informed consent and until the follow-up visit
Who cannot join
- Participation to another clinical trial where investigational drug was received, and last investigations were performed less than 8 weeks prior to screening;
- Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders, gastric surgery recent or in the past, and/or impaired gastric motility
- Clinically relevant abnormal laboratory values
- Abnormal liver enzymes at screening
- Subjects with history of breathing problems
- Positive HIV1 or HIV2 serology
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- Positive results from the Hepatitis serology
- Blood donation or blood loss (equal or more than 450 ml) less than 2 months prior to screening or before the first dosing;
- Positive urine test for cotinine
- Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test
- Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen
- Intake of non-permitted concomitant medications in the predefined period
- Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or before the first dosing;
- Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial;
- Known allergy to antifungal medicines;
- Unsuitable veins for repeated venipuncture;
- Heavy caffeine drinker
- For females only: pregnant or lactating women. Serum pregnancy test to be performed at screening and urine pregnancy test to be performed before the first dosing;
- Subjects receiving treatment with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) within the previous 3 months before the screening visit
- Subjects using e-cigarettes within 6 months before screening.
- Positive documented COVID-19 test before admission
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Life Sciences - Clinical Pharmacology Unit Antwerpen
Antwerp, 2060
About this study
Official title: Open-label, Non-randomized, One Sequence Cross-over Study to Investigate the Effect of Inhibition of CYP3A4/5 by Itraconazole on the Pharmacokinetics of CHF6001 in Healthy Subjects
The objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study.
Read the detailed description
This clinical trial is a single centre, single dose Phase I study, with a non-randomized, open label, one sequence cross-over design.
A total of 24 healthy male and female are planned to be included.
Participants will be dosed with CHF6001 before and during co-administration of Itraconazole and will act as their own control. The study will be run with a one-sequence crossover design, where all subjects will be treated with CHF6001 in the first treatment period and CHF6001+Itraconazole in the second treatment period in order to avoid the need of a very long washout from the CYP3A4/5 inhibitor.
Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood samples will be also collected for PK analysis.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- CHF6001 DPI, Itraconazole
- 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.
CHF6001 DPIDrug
Single dose of CHF6001
ItraconazoleDrug
Repeated doses of oral Itraconazole
| Study group | Role | What they receive |
|---|---|---|
| Treatment R | Experimental | Single dose of CHF6001 Receives: Drug: CHF6001 DPI |
| Treatment T | Experimental | Single dose of CHF6001 administered after repeated doses of oral Itraconazole Receives: Drug: CHF6001 DPI; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter (Cmax)
Peak Plasma Concentration (Cmax) for CHF6001
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUCt)
Area under the plasma concentration versus time curve (AUCt) for CHF6001
Measured: Over 96 hours after administration in blood
Secondary outcomes (7)
Pharmacokinetic parameter (AUC0-96)
Area under plasma concentration from 0 to 96 hours (AUC0-96) for CHF6001, CHF5956 and CHF6095
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUC0-∞)
Area under curve extrapolated to infinity (AUC0-∞) for CHF6001, CHF5956 and CHF6095
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (tmax)
Time of the maximum plasma concentration (tmax) for CHF6001, CHF5956 and CHF6095
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (t1/2)
Terminal half-life (t1/2) for CHF6001, CHF5956 and CHF6095
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (CL/F)
Apparent systemic clearance (CL/F) for CHF6001
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUCt)
Area under the plasma concentration versus time curve (AUCt) for CHF5956 and CHF6095
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (Cmax)
Peak Plasma Concentration (Cmax) for CHF5956 and CHF6095
Measured: Over 96 hours after administration in blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start22 Feb 2021
- Primary completion20 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- one sequence cross-over design
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739774
- Sponsor's protocol ID
- CLI-06001AA1-11
- Other IDs
- 2020-003769-21
- Status last verified
- May 2021
- First submitted
- 29 Jan 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomized, One Sequence Cross-over Study to Investigate the Effect of Inhibition of CYP3A4/5 by Itraconazole on the Pharmacokinetics of CHF6001 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04739774
- Acronym / sponsor ID
- CLI-06001AA1-11
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 5 Feb 2021 (actual)
- 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 objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study.
Detailed description
This clinical trial is a single centre, single dose Phase I study, with a non-randomized, open label, one sequence cross-over design.
A total of 24 healthy male and female are planned to be included.
Participants will be dosed with CHF6001 before and during co-administration of Itraconazole and will act as their own control. The study will be run with a one-sequence crossover design, where all subjects will be treated with CHF6001 in the first treatment period and CHF6001+Itraconazole in the second treatment period in order to avoid the need of a very long washout from the CYP3A4/5 inhibitor.
Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood samples will be also collected for PK analysis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one sequence cross-over design
| Arm | Type | Receives |
|---|---|---|
| Treatment R | Experimental | Drug: CHF6001 DPISingle dose of CHF6001 |
| Treatment T | Experimental | Drug: CHF6001 DPI, Drug: ItraconazoleSingle dose of CHF6001 administered after repeated doses of oral Itraconazole |
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;
- Healthy male and female subjects aged 18-55 years inclusive;
- Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly and to generate sufficient PIF using the In-Check device.
- Body Mass Index (BMI) between 18,0 and 35,0 kg/m2 extremes inclusive;
- Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year prior to screening;
Key exclusion criteria (21 listed)
- Participation to another clinical trial where investigational drug was received, and last investigations were performed less than 8 weeks prior to screening;
- Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders, gastric surgery recent or in the past, and/or impaired gastric motility
- Clinically relevant abnormal laboratory values
- Abnormal liver enzymes at screening
- Subjects with history of breathing problems
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 |
|---|---|---|
| CHF6001 DPISingle dose of CHF6001 | Drug | Treatment R, Treatment T |
| ItraconazoleRepeated doses of oral Itraconazole | Drug | Treatment T |
Primary outcome
Pharmacokinetic parameter (Cmax)
Time frame: Over 96 hours after administration in blood
Peak Plasma Concentration (Cmax) for CHF6001
Pharmacokinetic parameter (AUCt)
Time frame: Over 96 hours after administration in blood
Area under the plasma concentration versus time curve (AUCt) for CHF6001
7 secondary outcomes
Pharmacokinetic parameter (AUC0-96)
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUC0-∞)
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (tmax)
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (t1/2)
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (CL/F)
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUCt)
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (Cmax)
Time frame: Over 96 hours after administration in blood
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 5 May 2021.
- Individual participant dataSharing planned: No
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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.
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 CHF6001 DPI and Itraconazole in people with Chronic Obstructive Pulmonary Disease, 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 21 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 5 May 2021. 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?
Pharmacokinetic parameter (Cmax) (time frame: Over 96 hours after administration in blood). The study lists 2 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 5 May 2021.