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Chronic Obstructive Pulmonary DiseasePhase 1/2CHF6297 FIHNCT02815488

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPD

A Phase 1/2 study testing CHF6297 (Part 1 - SAD), CHF6297 (Part 2 - MAD) and CHF6297 (Part 3) in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 2 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an anti-inflammatory agent for the treatment of inflammatory airways diseases. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of CHF6297 as dry… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
CHF6297 (Part 1 - SAD), CHF6297 (Part 2 - MAD) and CHF6297 (Part 3)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
2 sitesUnited Kingdom
Study dates
22 Jan 2016to Mar 2019
Phase
Phase 1/2
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Part 1, Part 2, Part 4 (Healthy subjects):
  • Male subjects aged 18-55 years;
  • Non smokers
  • Lung function above 80% of predicted normal value
  • Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing
  • ability to produce an adequate induced sputum sample (study part 4 only)
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  • Part 3 (COPD patients):
  • Males and females aged 40-75 years
  • Current or past smokers
  • stable patients with a post-bronchodilator FEV1 between 40 and 80% of predicted normal value and FEV1/FVC ratio <0.7
  • Ability to produce a spontaneous and an adequate induced sputum sample

Who cannot join

  • Parts 1,2, 4 (Healthy subjects):
  • Any clinically relevant abnormalities and/or uncontrolled diseases
  • Abnormal laboratory values
  • Recent respiratory tract infection
  • Hypersensitivity to the drug or excipients
  • Positive serology results
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  • Positive cotinine, alcohol, drug of abuse tests
  • Part 3 (COPD patients):
  • Females of childbearing potential
  • History of asthma
  • Unstable concomitant diseases
  • Abnormal relevant Holter ECG parameters
  • Recent acute exacerbations of COPD or respiratory tract infection
  • Hypersensitivity to the drug or excipients
  • Positive serology results

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Medicines Evaluation Unit

    Manchester, M23 9QZ

  • Quotient Clinical

    Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF 6297 After Single and Repeated Ascending Doses in Healthy Male Subjects Followed by a Repeated Dose in COPD Patients and a 2-way, Crossover, Double-blind, Placebo-controlled, Repeated Dose Part to Investigate the Anti-inflammatory Effect of CHF 6297 After Lipopolysaccaride (LPS) Challenge in Healthy Male Subjects

CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an anti-inflammatory agent for the treatment of inflammatory airways diseases. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of CHF6297 as dry powder formulation in healthy subjects and in COPD patients. This study is the first administration in humans.

The study will comprise four parts:

Read more

Part 1 will consist of two cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6297.

Part 2 will consist of four cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6297.

Part 3 will consist of one cohort of COPD patients to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a repeat dose of CHF6297

Part 4 will consist of one cohort of healthy subjects to assess the anti-inflammatory effect of a repeat dose of CHF6297 after LPS challenge.

Being tested
CHF6297 (Part 1 - SAD), Placebo (Part 1 - SAD), CHF6297 (Part 2 - MAD), Placebo (Part 2 - MAD), CHF6297 (Part 3)
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.

  • CHF6297 (Part 1 - SAD)Drug

    Single doses of CHF6297 at each period (for up to 3 periods per subject)

  • Placebo (Part 1 - SAD)Drug

    Single doses of placebo matching CHF6297 at each period (for up to 3 periods per subject)

  • CHF6297 (Part 2 - MAD)Drug

    Twice daily doses of CHF6297 for 7 days

  • Placebo (Part 2 - MAD)Drug

    Twice daily doses of placebo matching CHF6297 for 7 days

  • CHF6297 (Part 3)Drug

    Twice daily doses of CHF6297 for 14 days

  • Placebo (Part 3)Drug

    Twice daily doses of placebo matching CHF6297 for 14 days

  • CHF6297 (Part 4)Drug

    Twice daily doses of CHF6297 for 7 days

  • Placebo (Part 4)Drug

    Twice daily doses of placebo matching CHF6297 for 7 days

Study groups in NCT02815488
Study groupRoleWhat they receive
CHF6297 ActiveExperimentalNot described
Receives: Drug: CHF6297 (Part 1 - SAD); Drug: CHF6297 (Part 2 - MAD); Drug: CHF6297 (Part 3); Drug: CHF6297 (Part 4)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo (Part 1 - SAD); Drug: Placebo (Part 2 - MAD); Drug: Placebo (Part 3); Drug: Placebo (Part 4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Treatment-related Adverse events

    Measured: Part 1 from Day 1 until Day 4, Part 2 from Day 1 until Day 8, Part 3 from Day 1 until Day 17, Part 4 from Day 1 until Day 8

  2. Change in Vital signs

    Blood pressure

    Measured: Part 1 from Day 1 until Day 4, Part 2 from Day 1 until Day 8, Part 3 from Day 1 until Day 17

  3. Change in Holter ECG parameters

    HR, QTcF, PR, QRS + holter recording abnormalities

    Measured: Part 1 Day 1-2, Part 2 Day 1-2 and Day 7-8, Part 3 Day 1-2 and Day 14-15

  4. Change in FEV1

    Forced exhalation volume in the first second

    Measured: Part 1 Day 1-2, Part 2 Day 1 and Day 7-8, Part 3 Day 1, Day 10 and Day 14

  5. Change in Laboratory parameters

    Clinical chemistry and haematology + urinalysis

    Measured: Part 1 Day 1 and Day 4, Part 2 Day 1 and Day 8, Part 3 Day 1 and Day 15

Secondary outcomes (9)

  1. Area under the plasma concentration vs time curve

    Measured: Part 1 Day 1 until Day 4, Part 2 Day 1 and Day 7, Part 3 Day 1 and Day 14

  2. Peak plasma concentration (Cmax)

    maximum plasma concentration of CHF6297

    Measured: Part 1 Day 1 until Day 4, Part 2 Day 1 and Day 7, Part 3 Day 1 and Day 14

  3. Time to reach the maximum plasma concentration (tmax)

    Measured: Part 1 Day 1 until Day 4, Part 2 Day 1 and Day 7, Part 3 Day 1 and Day 14

  4. Elimination half-life (t1/2)

    Measured: Part 1 Day 1 until Day 4, Part 2 Day 1 and Day 7, Part 3 Day 1 and Day 14

  5. Clearance (CL/F)

    Absolute plasma clearance

    Measured: Part 1 Day 1 until Day 4, Part 2 Day 1 and Day 7, Part 3 Day 1 and Day 14

  6. Volume of distribution (Vz/F)

    plasma volume of distribution

    Measured: Part 1 Day 1 until Day 4, Part 2 Day 1 and Day 7, Part 3 Day 1 and Day 14

  7. Urinary excretion (Ae)

    Amount of CHF6297 excreted in urine

    Measured: Part 1 from Day 1 to Day 4, Part 2 Day 1 and Day 7

  8. fraction excreted (fe)

    Percentage of drug excreted in urine

    Measured: Part 1 from Day 1 to Day 4, Part 2 Day 1 and Day 7

  9. Renal clearance (CLr)

    Measured: Part 1 from Day 1 to Day 4, Part 2 Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2016 (estimated)
  2. Study start22 Jan 2016
  3. Primary completionMar 2019
  4. Study completionMar 2019

Why it stopped: Very poor recruitment in the Part 4 of the study

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02815488
Sponsor's protocol ID
CCD-06297AA1-01
Other IDs
2015-003075-30, 2015
Acronym
CHF6297 FIH
Status last verified
Apr 2020
First submitted
25 May 2016
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CHF6297 (Part 1 - SAD), CHF6297 (Part 2 - MAD) and CHF6297 (Part 3) in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 2 sites 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Very poor recruitment in the Part 4 of the study). Results are not available in the source record.

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 (time frame: Part 1 from Day 1 until Day 4, Part 2 from Day 1 until Day 8, Part 3 from Day 1 until Day 17, Part 4 from Day 1 until Day 8). The study lists 5 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 NCT02815488.

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 17 Apr 2020.

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