Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT01703052
Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)
A Phase 1 study of Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to May 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject's written informed consent obtained prior to any study-related procedure
- Male healthy volunteers aged 18-55 years;
- Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
- 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;
- Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
- A reliable method of contraception for the subjects and their partner.
Who cannot join
- Blood donation or blood loss less than 8 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;
- History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
- Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
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- Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).
- Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre.
- Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled Double-blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers
This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.
Read the detailed description
The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part.
Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.
- Being tested
- CHF 6001 SD or placebo, CHF 6001 MD or 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.
CHF 6001 SD or placeboDrug
Also called CHF 6001 DPI
Dry Powder Inhaler
CHF 6001 MD or placeboDrug
Also called CHF 6001 DPI
Dry Powder Inhaler
| Study group | Role | What they receive |
|---|---|---|
| CHF 6001 SD or placebo | Experimental | Single administration of CHF 6001 dose levels 1 to 7 or placebo Receives: Drug: CHF 6001 SD or placebo |
| CHF 6001 MD or placebo | Experimental | Multiple administration of CHF 6001 dose levels 1 to 5 or placebo Receives: Drug: CHF 6001 MD or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, adverse drug reactions, serious adverse events.
The number and percentage of subjects with adverse events, adverse drug reactions, serious adverse events
Measured: After 7 days of treatment
Vital signs
Blood pressure and Heart rate
Measured: After 7 days of treatment
12-lead ECG
Heart rate, RR, PR, QRS, QT, QTcB, QTcF
Measured: After 7 days of treatment
24h ECG Holter
Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..)
Measured: After 7 days of treatment
FEV1
Measured: After 7 days of treatment
Blood and urine Laboratory tests
Measured: After 7 days of treatment
Body weight
Measured: After 7 days of treatment
Secondary outcomes (1)
Pharmacokinetics of CHF 6001 and its metabolite
AUC; Cmax and tmax; t½
Measured: After 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, MD, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703052
- Sponsor's protocol ID
- CCD-1006-PR-0048
- Status last verified
- Jul 2020
- First submitted
- 2 Apr 2012
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferrari A, Compagnoni A, Nandeuil A, Maison-Blanche P. Evaluation of the Effects of CHF6001, an Inhaled PDE4 Inhibitor, on Cardiac Repolarization and Cardiac Arrhythmias in Healthy Volunteers. J Cardiovasc Pharmacol. 2016 Jul;68(1):41-8. doi: 10.1097/FJC.0000000000000384.
PubMed 26945156Jolling K, Abelo A, Luyckx N, Nandeuil MA, Govoni M, Cella M, Lindauer A. Concentration-QT Modeling Following Inhalation of the Novel Inhaled Phosphodiesterase-4 Inhibitor CHF6001 in Healthy Volunteers Shows an Absence of QT Prolongation. CPT Pharmacometrics Syst Pharmacol. 2019 Jul;8(7):460-468. doi: 10.1002/psp4.12405. Epub 2019 May 11.
PubMed 31077576Mariotti F, Govoni M, Lucci G, Santoro D, Nandeuil MA. Safety, tolerability, and pharmacokinetics of single and repeat ascending doses of CHF6001, a novel inhaled phosphodiesterase-4 inhibitor: two randomized trials in healthy volunteers. Int J Chron Obstruct Pulmon Dis. 2018 Oct 18;13:3399-3410. doi: 10.2147/COPD.S174156. eCollection 2018.
PubMed 30425469
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Double-blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01703052
- Acronym / sponsor ID
- CCD-1006-PR-0048
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Oct 2012 (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.
This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.
Detailed description
The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part.
Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF 6001 SD or placebo | Experimental | Drug: CHF 6001 SD or placeboSingle administration of CHF 6001 dose levels 1 to 7 or placebo |
| CHF 6001 MD or placebo | Experimental | Drug: CHF 6001 MD or placeboMultiple administration of CHF 6001 dose levels 1 to 5 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject's written informed consent obtained prior to any study-related procedure
- Male healthy volunteers aged 18-55 years;
- Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
- 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;
Key exclusion criteria (9 listed)
- Blood donation or blood loss less than 8 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;
- History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
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 SD or placeboAlso: CHF 6001 DPIDry Powder Inhaler | Drug | CHF 6001 SD or placebo |
| CHF 6001 MD or placeboAlso: CHF 6001 DPIDry Powder Inhaler | Drug | CHF 6001 MD or placebo |
Primary outcome
Adverse events, adverse drug reactions, serious adverse events.
Time frame: After 7 days of treatment
The number and percentage of subjects with adverse events, adverse drug reactions, serious adverse events
Vital signs
Time frame: After 7 days of treatment
Blood pressure and Heart rate
12-lead ECG
Time frame: After 7 days of treatment
Heart rate, RR, PR, QRS, QT, QTcB, QTcF
24h ECG Holter
Time frame: After 7 days of treatment
Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..)
FEV1
Time frame: After 7 days of treatment
Blood and urine Laboratory tests
Time frame: After 7 days of treatment
Body weight
Time frame: After 7 days of treatment
1 secondary outcome
Pharmacokinetics of CHF 6001 and its metabolite
Time frame: After 7 days of treatment
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 31 Jul 2020.
- Background: PubMed 26945156Ferrari A, Compagnoni A, Nandeuil A, Maison-Blanche P. Evaluation of the Effects of CHF6001, an Inhaled PDE4 Inhibitor, on Cardiac Repolarization and Cardiac Arrhythmias in Healthy Volunteers. J Cardiovasc Pharmacol. 2016 Jul;68(1):41-8. doi: 10.1097/FJC.0000000000000384.
- Background: PubMed 31077576Jolling K, Abelo A, Luyckx N, Nandeuil MA, Govoni M, Cella M, Lindauer A. Concentration-QT Modeling Following Inhalation of the Novel Inhaled Phosphodiesterase-4 Inhibitor CHF6001 in Healthy Volunteers Shows an Absence of QT Prolongation. CPT Pharmacometrics Syst Pharmacol. 2019 Jul;8(7):460-468. doi: 10.1002/psp4.12405. Epub 2019 May 11.
- Results publication: PubMed 30425469Mariotti F, Govoni M, Lucci G, Santoro D, Nandeuil MA. Safety, tolerability, and pharmacokinetics of single and repeat ascending doses of CHF6001, a novel inhaled phosphodiesterase-4 inhibitor: two randomized trials in healthy volunteers. Int J Chron Obstruct Pulmon Dis. 2018 Oct 18;13:3399-3410. doi: 10.2147/COPD.S174156. eCollection 2018.
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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.
Stuart Mair, MD principal investigator
Quotient Clinical
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 of Chronic Obstructive Pulmonary Disease (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 7 inclusion and 9 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 31 Jul 2020. 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?
Adverse events, adverse drug reactions, serious adverse events. (time frame: After 7 days of treatment). 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?
On the ClinicalTrials.gov record for NCT01703052, which also lists 3 linked publications.
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 31 Jul 2020.