Chronic Obstructive Pulmonary DiseasePhase 1NCT06395610
Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers
A Phase 1 study testing CHF6001 DPI and Erythromycin in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
Trial summary
The objective of this study is to investigate the effect of the interaction of Erythromycin (CYP3A4/5 moderate inhibitor) on the pharmacokinetic of CHF6001 (CYP3A4/5 substrate) in Healthy Volunteers. 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 Erythromycin
- 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 siteBulgaria
- Study dates
- 28 Mar 2024to 18 Jun 2024
- 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 peak inspiratory flow (PIF) using the In Check device set as per NEXThaler® inhaler resistance;
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 extremes inclusive;
- Non- or ex-smokers who smoked <5 pack-years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking >1 year prior to screening;
- Good physical and mental status determined based on the medical history and a general clinical examination, at screening and before the first dosing;
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- Vital signs within normal limits at screening: diastolic blood pressure (DBP) 40-90 mmHg, systolic blood pressure (SBP) 90 140 mmHg (two measures performed after at least 5 min of resting; the mean value must be within the defined range);
- A 12-lead digitalised electrocardiogram (ECG) considered as normal at screening: 40 bpm ≤ heart rate (HR) ≤110 bpm; 120 ms ≤ time interval between the P and R wave in the ECG (PR) ≤210 ms; 80 ms ≤ time interval between the Q and R and S wave in the ECG (QRS) ≤120 ms; Fridericia-corrected time interval between the Q and T wave in the ECG (QTcF) ≤450 ms for males and ≤470 ms for females;
- Pulmonary function test within normal limits at screening: forced expiratory volume in the first second (FEV1) % predicted >80% and FEV1/forced vital capacity (FVC) ratio >0.70 (American Thoracic Society and European Respiratory Society [ATS/ERS] Task Force, 2019);
- Female subjects:
- Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method preferably with low user dependency (with exception of combined or progestogen-only hormonal contraception) from the signature of the informed consent and until the follow-up contact, or ii.WOCBP with non-fertile male partners: contraception is not required in this case;
- For the definition of WOCBP and of fertile men and the list of birth control methods with low user dependency, refer to Appendix 2 (or Section 4.1 of the Clinical Trial Facilitation Group guidance for more detailed information);
- Or
- Women of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. postmenopausal, or permanently sterile as per definitions given in Appendix 2). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per Investigator's request, postmenopausal status may be confirmed by follicle-stimulating hormone (FSH) levels (according to local laboratory ranges).
Who cannot join
- Participation in 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 recently or in the past, and/or impaired Inclusion criteria: gastric motility that may interfere with successful completion of this protocol according to the Investigator's judgment;
- Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator's judgment;
- Abnormal liver enzymes at screening (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >1.5x upper limit of normal [ULN]), bilirubin >1.5x ULN);
- Subjects with history of breathing problems (e.g. history of asthma). Allergic asthma diagnosis in childhood (until 12 years old) is allowed;
- Positive human immunodeficiency virus 1 or 2 (HIV1 or HIV2) serology at screening;
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- Positive results from the hepatitis serology which indicates acute or chronic hepatitis B (HB) or hepatitis C (HC) at screening (i.e. positive HB surface antigen [HBsAg], HB core antibody [IgM anti-HBc], HC antibody);
- Blood donation or blood loss (equal or more than 450 mL) less than 8 weeks prior to screening or before the first dosing;
- Positive urine test for cotinine at screening and before the first dosing;
- Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test at screening and before Treatment Period 1, Day -1;
- Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen evaluated at screening and before the first dosing;
- Intake of non-permitted concomitant medication in the predefined period prior to screening or before the first dosing or the subject is expected to take non-permitted concomitant medication during the study;
- Presence of any current infection, or previous infection that resolved less than 7 days prior to screening and before the first dosing;
- Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial;
- Unsuitable arm veins for repeated venipuncture;
- Heavy caffeine drinker (>5 cups or glasses of caffeinated beverages, e.g. coffee, tea, cola per day);
- For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin laboratory test. 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, fluconazole, itraconazole, etc.) within the 3 months preceding the screening visit;
- Subjects using e-cigarettes within 6 months before screening;
- Positive test for coronavirus disease 2019 (COVID-19) (antibody test or nucleic acid test) within 14 days prior to screening and the associated complications/symptoms, which have not resolved within 14 days prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Non-randomised, One-sequence Crossover Study to Investigate the Effect of Inhibition of CYP3A4/5 by Erythromycin on the Pharmacokinetics of CHF6001 in Healthy Subjects
The objective of this study is to investigate the effect of the interaction of Erythromycin (CYP3A4/5 moderate inhibitor) on the pharmacokinetic of CHF6001 (CYP3A4/5 substrate) in Healthy Volunteers.
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 Erythromycin 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+ Erythromycin 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, Erythromycin
- Keywords
- Drug-drug Interaction study, CYP3A4/5 inhibitor, CYP3A4/5 substrate
- 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
ErythromycinDrug
Repeated doses of oral Erythromycin
| 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 Erythromycin Receives: Drug: CHF6001 DPI; Drug: Erythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter (AUC0-t)
Area under the curve from time 0 to the last quantifiable concentration (AUC0-t)
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (Cmax)
Maximum plasma concentration (Cmax) of CHF6001 without and with the concomitant administration of Erythromycin
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 to the maximum plasma concentration (tmax) for CHF6001, CHF5956 and CHF6095
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (CL/F)
Apparent systemic clearance for CHF6001
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (t1/2)
Terminal elimination half-life (t1/2) for CHF6001, CHF5956 and CHF6095
Measured: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUC0-t)
Area under the plasma concentration versus time curve (AUC0-t) 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 posted2 May 2024
- Study start28 Mar 2024
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
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
- 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
- NCT06395610
- Sponsor's protocol ID
- CLI-06001AA1-14
- Other IDs
- 2023-507300-30-00, 2023
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomised, One-sequence Crossover Study to Investigate the Effect of Inhibition of CYP3A4/5 by Erythromycin on the Pharmacokinetics of CHF6001 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06395610
- Acronym / sponsor ID
- CLI-06001AA1-14
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Drug-drug Interaction study, CYP3A4/5 inhibitor, CYP3A4/5 substrate
- 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
- 28 Mar 2024 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 2 May 2024 (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 study is to investigate the effect of the interaction of Erythromycin (CYP3A4/5 moderate inhibitor) on the pharmacokinetic of CHF6001 (CYP3A4/5 substrate) in Healthy Volunteers.
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 Erythromycin 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+ Erythromycin 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
| Arm | Type | Receives |
|---|---|---|
| Treatment R | Experimental | Drug: CHF6001 DPISingle dose of CHF6001 |
| Treatment T | Experimental | Drug: CHF6001 DPI, Drug: ErythromycinSingle dose of CHF6001 administered after repeated doses of oral Erythromycin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 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 peak inspiratory flow (PIF) using the In Check device set as per NEXThaler® inhaler resistance;
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 extremes inclusive;
- Non- or ex-smokers who smoked <5 pack-years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking >1 year prior to screening;
Key exclusion criteria (20 listed)
- Participation in 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 recently or in the past, and/or impaired Inclusion criteria: gastric motility that may interfere with successful completion of this protocol according to the Investigator's judgment;
- Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator's judgment;
- Abnormal liver enzymes at screening (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >1.5x upper limit of normal [ULN]), bilirubin >1.5x ULN);
- Subjects with history of breathing problems (e.g. history of asthma). Allergic asthma diagnosis in childhood (until 12 years old) is allowed;
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 |
| ErythromycinRepeated doses of oral Erythromycin | Drug | Treatment T |
Primary outcome
Pharmacokinetic parameter (AUC0-t)
Time frame: Over 96 hours after administration in blood
Area under the curve from time 0 to the last quantifiable concentration (AUC0-t)
Pharmacokinetic parameter (Cmax)
Time frame: Over 96 hours after administration in blood
Maximum plasma concentration (Cmax) of CHF6001 without and with the concomitant administration of Erythromycin
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 (CL/F)
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (t1/2)
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUC0-t)
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 3 Jul 2024.
- 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 Erythromycin in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
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 14 inclusion and 20 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 3 Jul 2024. 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 Bulgaria. 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 (AUC0-t) (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 3 Jul 2024.