CopdPhase 1NCT03004495
Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001
A Phase 1 study testing CHF5259 and CHF6001 in people with Copd, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of CHF6001 and CHF5259, in comparison with the single components, administered in healthy subjects via a multi-dose reservoir NEXThaler® DPI. 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?
- CHF5259 and CHF6001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Aug 2016
- 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 males and females volunteers aged 18-55 years inclusive;
- Ability to understand the study procedures and the involved risks, ability to be trained to use the device correctly
- Non smokers or ex-smokers are eligible.
- Good physical and mental status, determined on the basis of the medical history and a general clinical examination;
- Vital signs checked at screening visit and Day -1: Subjects aged 18-45years: Diastolic BP 40-90, Systolic BP 90-140; Subjects aged 46-55 years: Diastolic BP 40-90, Systolic BP 90-150
- 12-lead digitised Electrocardiogram (12-lead ECG) considered as normal (40≤Heart rate≤110bpm,120 ms ≤ PR ≤ 210 ms, QRS ≤ 120 ms, QTcF ≤ 450 ms for males and ≤ 470ms for females) checked at screening;
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- Lung function measurements within normal limits: FEV1 > 80% of predicted normal value (according to the Global Lung Function Initiative, ERS Task Force Lung Function Reference Values (1,2) ) and FEV1/FVC ratio > 0.70;
- Male subjects: they and/or their partner of childbearing potential must be willing to use a double contraceptive methods;
- Female subject of non-childbearing potential (WONCBP) Female subjects of childbearing potential (WOCBP) fulfilling one of the following criteria: WOCBP with fertile male partners: they and/or their partner of childbearing potential must be willing to use a double contraceptive methods including one highly effective birth control method and one acceptable birth control method, from the signature of the informed consent and until three months following the last study drug intake; WOCBP with non-fertile male partners: contraception is not required in this case.
Who cannot join
- Pregnant or lactating women:
- Blood donation (equal or more than 450 ml) or blood loss less than 12 weeks before inhalation of the study medication;
- Positive HIV1 or HIV2 serology; Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C (positive HB surface antigen (HBsAg),HB core antibody ( anti HBc), HC antibody);
- History of substance abuse or drug abuse within 12 months prior to screening visit;
- Clinically significant abnormal 24-h Holter ECG at screening as defined in the Holter interpretative guidelines (Appendix V);
- Any clinically relevant abnormal laboratory value 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;
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- Clinically significant and uncontrolled respiratory, cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, respiratory or psychiatric disorder that may interfere with successful completion of this protocol;
- Subjects with medical diagnosis asthma including childhood asthma;
- Subjects known to have intolerance/ hypersensitivity to M3 Antagonists, or any of the excipients contained in any of 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 (3 months for any biologic drugs, enzyme-inducing or enzyme-inhibiting drugs e.g., glucocorticoids, phenobarbital, isoniazid) before the screening visit, 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 with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, Repeated-dose, 3-way Crossover Study to Investigate Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001 Administered in Healthy Subjects Via NEXThaler® Dry Powder Inhaler
To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of CHF6001 and CHF5259, in comparison with the single components, administered in healthy subjects via a multi-dose reservoir NEXThaler® DPI.
Read the detailed description
This is randomised open label, 3-way cross-over study. Each 14-day treatment period is separated from the following one by a 21-day wash-out period. Subjects will reside at the clinic facilities during the 14 days treatment period.
- Conditions
- Copd
- Being tested
- CHF5259 and CHF6001, CHF5259 + placebo, CHF6001 + placebo, Placebo
- 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.
CHF5259 and CHF6001Drug
Also called Test Treatment
b.i.d. for 14 days
CHF5259 + placeboDrug
Also called Reference Treatment 1
b.i.d. for 14 days
CHF6001 + placeboDrug
Also called Reference Treatment 2
b.i.d. for 14 days
PlaceboOther
Also called Matching number of inhalations
b.i.d. for 14 days
| Study group | Role | What they receive |
|---|---|---|
| CHF5259 and CHF6001 | Experimental | (T): CHF6001 + CHF5259 b.i.d. for 14 days Receives: Drug: CHF5259 and CHF6001 |
| CHF5259 + placebo | Active comparator | (R1): CHF5259 25µg b.i.d. for 14 days Receives: Drug: CHF5259 + placebo; Other: Placebo |
| CHF6001 + placebo | Active comparator | (R2): CHF6001 b.i.d. for 14 days Receives: Drug: CHF6001 + placebo; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma CHF 5259 and CHF 6001 AUC 0-12,ss (area under the plasma concentration-time curve from time 0 to 12h post dose at steady on Day 14)
To evaluate the pharmacokinetic interaction between CHF 5259 and CHF 6001
Measured: On Day 1 and Day 14 at pre-dose, within 15 minutes from dosing and at the following time points, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post morning dose. At Day 8, Day 12 and Day 13 at pre-dose
Plasma CHF 5259 and CHF 6001 Cmax,ss (maximum plasma concentration at steady state on Day 14)
To evaluate the pharmacokinetic interaction between CHF 5259 and CHF 6001
Measured: On Day 1 and Day 14 at pre-dose, within 15 minutes from dosing and at the following time points, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post morning dose. At Day 8, Day 12 and Day 13 at pre-dose
Secondary outcomes (6)
Plasma CHF 5259 and CHF 6001 and its metabolites (CHF 5956, CHF 6095) AUC0-12h, Cmax, tmax
Measured: On Day 1, Day 14 at the following time points: pre-dose, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post-morning dose.
Holter extracted ECG parameters
Measured: On Day 1, Day 14 at the following time points: pre-dose, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post-morning dose.
Lung function
Measured: On Day 1, Day 14: at pre-dose, 5, 15, 30, 45 min and 1, 2 hours post-morning dose
Vital signs
Measured: On Day 1, Day 8 and on Day 14 at the following time points: pre-dose, 15 min, 30 min, 1, 2, 4, 8, 12 h post morning dose. From Day 2 to Day 13 at pre-morning dose only, On Day 15 (24 h after last dose), Day 16 (48 h after last dose) and at follow-up. (BP
Plasma CHF 5259 and CHF 6001 and its metabolites (CHF 5956, CHF 6095) Cmax
Measured: On Day 1, Day 14 at the following time points: pre-dose, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post-morning dose.
Plasma CHF 5259 and CHF 6001 and its metabolites (CHF 5956, CHF 6095) tmax
Measured: On Day 1, Day 14 at the following time points: pre-dose, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post-morning dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionAug 2016
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Ronnie Beboso, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004495
- Sponsor's protocol ID
- CCD-06302AA1-02
- Status last verified
- Dec 2016
- First submitted
- 28 Oct 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Repeated-dose, 3-way Crossover Study to Investigate Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001 Administered in Healthy Subjects Via NEXThaler® Dry Powder Inhaler
- ClinicalTrials.gov ID
- NCT03004495
- Acronym / sponsor ID
- CCD-06302AA1-02
- Conditions
- Copd
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Dec 2016 (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.
To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of CHF6001 and CHF5259, in comparison with the single components, administered in healthy subjects via a multi-dose reservoir NEXThaler® DPI.
Detailed description
This is randomised open label, 3-way cross-over study. Each 14-day treatment period is separated from the following one by a 21-day wash-out period. Subjects will reside at the clinic facilities during the 14 days treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF5259 and CHF6001 | Experimental | Drug: CHF5259 and CHF6001(T): CHF6001 + CHF5259 b.i.d. for 14 days |
| CHF5259 + placebo | Active comparator | Drug: CHF5259 + placebo, Other: Placebo(R1): CHF5259 25µg b.i.d. for 14 days |
| CHF6001 + placebo | Active comparator | Drug: CHF6001 + placebo, Other: Placebo(R2): CHF6001 b.i.d. for 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject's written informed consent obtained prior to any study-related procedure; Healthy males and females volunteers aged 18-55 years inclusive;
- Ability to understand the study procedures and the involved risks, ability to be trained to use the device correctly
- Non smokers or ex-smokers are eligible.
- Good physical and mental status, determined on the basis of the medical history and a general clinical examination;
- Vital signs checked at screening visit and Day -1: Subjects aged 18-45years: Diastolic BP 40-90, Systolic BP 90-140; Subjects aged 46-55 years: Diastolic BP 40-90, Systolic BP 90-150
Key exclusion criteria (11 listed)
- Pregnant or lactating women:
- Blood donation (equal or more than 450 ml) or blood loss less than 12 weeks before inhalation of the study medication;
- Positive HIV1 or HIV2 serology; Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C (positive HB surface antigen (HBsAg),HB core antibody ( anti HBc), HC antibody);
- History of substance abuse or drug abuse within 12 months prior to screening visit;
- Clinically significant abnormal 24-h Holter ECG at screening as defined in the Holter interpretative guidelines (Appendix V);
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 |
|---|---|---|
| CHF5259 and CHF6001Also: Test Treatmentb.i.d. for 14 days | Drug | CHF5259 and CHF6001 |
| CHF5259 + placeboAlso: Reference Treatment 1b.i.d. for 14 days | Drug | CHF5259 + placebo |
| CHF6001 + placeboAlso: Reference Treatment 2b.i.d. for 14 days | Drug | CHF6001 + placebo |
| PlaceboAlso: Matching number of inhalationsb.i.d. for 14 days | Other | CHF5259 + placebo, CHF6001 + placebo |
Primary outcome
Plasma CHF 5259 and CHF 6001 AUC 0-12,ss (area under the plasma concentration-time curve from time 0 to 12h post dose at steady on Day 14)
Time frame: On Day 1 and Day 14 at pre-dose, within 15 minutes from dosing and at the following time points, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post morning dose. At Day 8, Day 12 and Day 13 at pre-dose
To evaluate the pharmacokinetic interaction between CHF 5259 and CHF 6001
Plasma CHF 5259 and CHF 6001 Cmax,ss (maximum plasma concentration at steady state on Day 14)
Time frame: On Day 1 and Day 14 at pre-dose, within 15 minutes from dosing and at the following time points, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post morning dose. At Day 8, Day 12 and Day 13 at pre-dose
To evaluate the pharmacokinetic interaction between CHF 5259 and CHF 6001
6 secondary outcomes
Plasma CHF 5259 and CHF 6001 and its metabolites (CHF 5956, CHF 6095) AUC0-12h, Cmax, tmax
Time frame: On Day 1, Day 14 at the following time points: pre-dose, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post-morning dose.
Holter extracted ECG parameters
Time frame: On Day 1, Day 14 at the following time points: pre-dose, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post-morning dose.
Lung function
Time frame: On Day 1, Day 14: at pre-dose, 5, 15, 30, 45 min and 1, 2 hours post-morning dose
Vital signs
Time frame: On Day 1, Day 8 and on Day 14 at the following time points: pre-dose, 15 min, 30 min, 1, 2, 4, 8, 12 h post morning dose. From Day 2 to Day 13 at pre-morning dose only, On Day 15 (24 h after last dose), Day 16 (48 h after last dose) and at follow-up. (BP
Plasma CHF 5259 and CHF 6001 and its metabolites (CHF 5956, CHF 6095) Cmax
Time frame: On Day 1, Day 14 at the following time points: pre-dose, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post-morning dose.
Plasma CHF 5259 and CHF 6001 and its metabolites (CHF 5956, CHF 6095) tmax
Time frame: On Day 1, Day 14 at the following time points: pre-dose, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post-morning dose.
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 29 Dec 2016.
- 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.
Ronnie Beboso, MD principal investigator
Quintiles, Inc.
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 CHF5259 and CHF6001 in people with Copd, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
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 11 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 29 Dec 2016. 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 United Kingdom. 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?
Plasma CHF 5259 and CHF 6001 AUC 0-12,ss (area under the plasma concentration-time curve from time 0 to 12h post dose at steady on Day 14) (time frame: On Day 1 and Day 14 at pre-dose, within 15 minutes from dosing and at the following time points, 5, 10, 15, 30, 45 min and 1, 1.5, 2, 3, 4, 6, 8, 12 h post morning dose. At Day 8, Day 12 and Day 13 at pre-dose). 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 29 Dec 2016.