Chronic Obstructive Pulmonary DiseasePhase 1NCT05431426
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers
A Phase 1 study testing CH6001 in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
Trial summary
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same setting. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- CH6001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBulgaria
- Study dates
- 29 Jul 2022to 27 Dec 2022
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects:
- Subject's written informed consent obtained prior to any study-related procedure;
- Male and female subjects aged 40 to 80 years inclusive at screening;
- Ability to understand the study procedures and the risks involved, and ability to be trained to use the inhalers correctly and to generate sufficient peak inspiratory flow (PIF, at least 40 L/min) using the In-Check device set as per NEXThaler® inhaler resistance;
- Subjects must weigh at least 45kg for females and 50 kg for males to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2 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;
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- Oral body temperature < 37.5°C;
- Mean values of triplicate recording of 12-lead digitised electrocardiogram (ECG) considered as normal (40 beats per min [bpm] ≤ heart rate [HR] ≤ 110 bpm, 120 ms ≤ PR interval [PR] ≤ 210 ms, QRS interval [QRS] ≤ 120 ms, QT interval corrected using Fridericia's formula [QTcF] ≤ 450 ms for males and QTcF ≤ 470 ms for females);
- Lung function measurements within normal limits at screening: forced expiratory volume within the first second (FEV1) > 80% predicted and FEV1/Forced vital capacity (FVC) ratio > 0.70;
- For female subjects:
- Women of child bearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use at least an acceptable effective birth control method from the signature of the informed consent and until follow up contact; or ii. WOCBP with non-fertile male partners (contraception is not required in this case); b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant. Tubal ligation or partial surgical interventions are not acceptable;
- Healthy subjects only:
- Good mental and physical status, determined on the basis of the medical history and a general clinical examination;
- Blood pressure within normal limits at screening and prior to study treatment administration: diastolic blood pressure (DBP) 40-89 mmHg and systolic blood pressure (SBP) 90-139 mmHg, extremes included;
- Serum creatinine within the normal range and an eGFR ≥ 90 mL/min/1.73 m2 as determined by the MDRD equation;
- Matched to at least one renal impaired subject enrolled in the study with respect to age (±10 years), gender, race and body weight (±15%);
- Renal impaired subjects only:
- Good mental status, determined on the basis of the medical history and a general clinical examination;
- Blood pressure at screening and prior to study treatment administration: DBP 40 100 mmHg and SBP 90 170 mmHg, extremes included;
- Subjects must have a chronic stable renal disease based on the medical history, physical examination, and clinical laboratory results:
- "Chronic" is defined as > 6 months;
- "Stable" is defined as the absence of significant progression and/or deterioration of the renal disease for the past 12 weeks (fluctuations in creatinine levels within ±20% in the last 12 weeks are accepted); Subjects may have concurrent stable medical conditions in addition to renal impairment, but may be included only if the Investigator, in consultation with the Sponsor's Clinical Research Physician, considers that the condition will not introduce an additional risk factor, and will not interfere with the study objectives and procedures (e.g. subjects with stable diabetes or essential hypertension may be included);
- Subjects with renal impairment must have the following absolute eGFR values as determined by the MDRD equation: mild renal impairment must have an absolute eGFR of ≥ 60 to < 90 mL/min/1.73 m2; moderate renal impairment must have an absolute eGFR of ≥ 30 to < 60 mL/min/1.73 m2; severe renal impairment must have an absolute eGFR of < 30 mL/min/1.73 m2 not requiring dialysis.
Who cannot join
- All subjects:
- Participation to another clinical study where an investigational treatment was received, and last investigations were performed less than 8 weeks prior to screening;
- Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);
- Positive human immunodeficiency virus (HIV) 1 or HIV2 serology;
- Positive results from the Hepatitis serology which indicates acute or chronic hepatitis B or hepatitis C at screening (i.e. positive hepatitis B surface antigen [HBsAg], hepatitis B core antibody [immunoglobulin M antibody to hepatitis B core antigen, IgM anti-HBc], hepatitis C virus [HCV] antibody);
- Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks, or complications from this disease, which have not resolved within 14 days prior to screening or to study treatment administration;
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- Blood donation or blood loss (≥ 450 mL) less than 2 months prior to screening or prior to study treatment administration;
- Abnormal liver enzymes at screening (alanine aminotransferase [ALT] or Aspartate aminotransferase [AST] > 1.5 times the upper limit of normal [ULN], total bilirubin > 1.5 times the ULN);
- Current haemodialysis or peritoneal dialysis or indications for these procedures;
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of orally administered drugs (e.g. history of bariatric surgery, stomach/intestinal significant resection, portacaval shunting);
- Subject with severe heart failure as defined by the New York Heart Association functional classification III and IV;
- 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 evaluated at screening or prior to study drug administration;
- Intake of non-permitted concomitant medications;
- Presence of any current infection, or previous infection that resolved less than 7 days;
- Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
- Unsuitable veins for repeated venepuncture;
- Heavy caffeine drinker (average of > 5 cups or glasses per day of caffeinated beverages e.g. coffee, tea, cola, calculated by number of standard espresso portions);
- 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;
- Contra-indications/warnings/precaution for use: contra indications to the investigational medicinal product (IMP) constitute an exclusion criterion;
- The use of any kind of smoking electronic devices within 6 months before screening;
- Healthy subjects only:
- Abnormal haemoglobin [Hb] level defined as < 130 g/L for males and < 110 g/L for females at screening;
- Current diagnosis or history of nephrolithiasis (kidney stone);
- Clinically relevant and uncontrolled respiratory, cardiovascular, hepatic, gastrointestinal, renal, endocrine, metabolic (especially subjects with deficiency in glucuronidation), neurologic, haematologic, neoplastic or psychiatric disorders that may interfere with successful completion of this study 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;
- Renal impaired subjects only:
- Abnormal Hb level defined as ≤ 80 g/L at screening;
- Clinically relevant and/or uncontrolled respiratory, cardiovascular, hepatic, gastrointestinal, endocrine, metabolic (especially subjects with deficiency in glucuronidation), neurologic, haematologic, neoplastic or psychiatric disorders that may interfere with successful completion of this study;
- Acute renal disease caused by drug toxicity;
- History of clinically significant (CS) chronic or recurrent urinary tract infection, active and requiring antibiotic treatment within the past 30 days;
- Secondary renal disease associated with impaired liver metabolism (hepatorenal syndrome) or due to malignancy;
- Significant risk factors for progression of the renal disease within 3 months prior to screening (e.g. uremic pericarditis, pleuritis, bleeding disorders, eGFR < 15 mL/min/m2);
- Subjects who underwent a nephrectomy;
- Subjects with a functioning organ transplant or who are registered on a transplant list.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Non-randomised, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same setting.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- CH6001
- Keywords
- Renal impairment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH6001Drug
CHF6001 will be administered using the NEXThaler® DPI device
| Study group | Role | What they receive |
|---|---|---|
| Mild renal impaired subjects | Experimental | Administration of a single dose of CH6001 800 µg in mild renal impaired subjects. Receives: Drug: CH6001 |
| Moderate renal impaired subjects | Experimental | Administration of a single dose of CH6001 800 µg in moderate renal impaired subjects. Receives: Drug: CH6001 |
| Severe renal impaired subjects | Experimental | Administration of a single dose of CH6001 800 µg in severe renal impaired subjects. Receives: Drug: CH6001 |
| Healthy volunteers | Experimental | Administration of a single dose of CH6001 800 µg in healthy volunteers. Receives: Drug: CH6001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Curve (AUC) of total plasma CHF6001
Area under the plasma concentration versus time curve for total plasma CHF6001 after a single-dose of CHF6001
Measured: Over 240 hours after CHF6001 administration
Maximum of Concentration (Cmax) of total plasma CHF6001
Peak plasma concentration for total plasma CHF6001 after a single-dose of CHF6001
Measured: Over 240 hours after CHF6001 administration
Secondary outcomes (10)
Pharmacokinetic parameter ( Cmax)
Peak Plasma Concentration (Cmax) for CHF6001 unbound plasma
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUCt)
Area under the plasma concentration versus time curve (AUCt) for CHF6001 unbound plasma
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUC0-72)
Area under plasma concentration from 0 to 72hours (AUC0-72) for CHF6001, CHF5956 and CHF6095
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUC0-240)
Area under plasma concentration from 0 to 240hours (AUC0-240) for CHF6001, CHF5956 and CHF6095
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUC0-∞)
Area under plasma concentration from 0 to infinity(AUC0-∞) for CHF6001, CHF5956 and CHF6095
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (tmax)
Time of the maximum plasma concentration (tmax) for CHF6001, CHF5956 and CHF6095
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (t1/2)
Terminal half-life (t1/2) for CHF6001, CHF5956 and CHF6095
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (CL/F)
Apparent systemic clearance (CL/F) for CHF6001
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUCt)
Area under the plasma concentration versus time curve (AUCt) for CHF5956 and CHF6095
Measured: Over 240 hours after administration in blood
Pharmacokinetic parameter (Cmax)
Peak Plasma Concentration (Cmax) for CHF5956 and CHF6095
Measured: Over 240 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 posted24 Jun 2022
- Study start29 Jul 2022
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT05431426
- Sponsor's protocol ID
- CLI-06001AA1-07
- Other IDs
- 2021-005567-43
- Status last verified
- Jan 2023
- First submitted
- 31 May 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piccinno A, Pittelli MG, Balzano D, Rizzo E, Bellatti P, Rostello C, Emirova A. Evaluating the Impact of Hepatic or Renal Impairment on Tanimilast (CHF6001) Pharmacokinetics: Two Open-Label, Parallel-Group, Single-Center Studies. Clin Transl Sci. 2025 May;18(5):e70261. doi: 10.1111/cts.70261.
PubMed 40391696
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomised, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT05431426
- Acronym / sponsor ID
- CLI-06001AA1-07
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Renal impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 24 Jun 2022 (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 purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same setting.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild renal impaired subjects | Experimental | Drug: CH6001Administration of a single dose of CH6001 800 µg in mild renal impaired subjects. |
| Moderate renal impaired subjects | Experimental | Drug: CH6001Administration of a single dose of CH6001 800 µg in moderate renal impaired subjects. |
| Severe renal impaired subjects | Experimental | Drug: CH6001Administration of a single dose of CH6001 800 µg in severe renal impaired subjects. |
| Healthy volunteers | Experimental | Drug: CH6001Administration of a single dose of CH6001 800 µg in healthy volunteers. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subject's written informed consent obtained prior to any study-related procedure;
- Male and female subjects aged 40 to 80 years inclusive at screening;
- Ability to understand the study procedures and the risks involved, and ability to be trained to use the inhalers correctly and to generate sufficient peak inspiratory flow (PIF, at least 40 L/min) using the In-Check device set as per NEXThaler® inhaler resistance;
- Subjects must weigh at least 45kg for females and 50 kg for males to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2 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 (36 listed)
- Participation to another clinical study where an investigational treatment was received, and last investigations were performed less than 8 weeks prior to screening;
- Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);
- Positive human immunodeficiency virus (HIV) 1 or HIV2 serology;
- Positive results from the Hepatitis serology which indicates acute or chronic hepatitis B or hepatitis C at screening (i.e. positive hepatitis B surface antigen [HBsAg], hepatitis B core antibody [immunoglobulin M antibody to hepatitis B core antigen, IgM anti-HBc], hepatitis C virus [HCV] antibody);
- Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks, or complications from this disease, which have not resolved within 14 days prior to screening or to study treatment administration;
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 |
|---|---|---|
| CH6001CHF6001 will be administered using the NEXThaler® DPI device | Drug | Healthy volunteers, Mild renal impaired subjects, Moderate renal impaired subjects, Severe renal impaired subjects |
Primary outcome
Area under the Curve (AUC) of total plasma CHF6001
Time frame: Over 240 hours after CHF6001 administration
Area under the plasma concentration versus time curve for total plasma CHF6001 after a single-dose of CHF6001
Maximum of Concentration (Cmax) of total plasma CHF6001
Time frame: Over 240 hours after CHF6001 administration
Peak plasma concentration for total plasma CHF6001 after a single-dose of CHF6001
10 secondary outcomes
Pharmacokinetic parameter ( Cmax)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUCt)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUC0-72)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUC0-240)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUC0-∞)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (tmax)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (t1/2)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (CL/F)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (AUCt)
Time frame: Over 240 hours after administration in blood
Pharmacokinetic parameter (Cmax)
Time frame: Over 240 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 26 Jan 2023.
- Derived from this study: PubMed 40391696Piccinno A, Pittelli MG, Balzano D, Rizzo E, Bellatti P, Rostello C, Emirova A. Evaluating the Impact of Hepatic or Renal Impairment on Tanimilast (CHF6001) Pharmacokinetics: Two Open-Label, Parallel-Group, Single-Center Studies. Clin Transl Sci. 2025 May;18(5):e70261. doi: 10.1111/cts.70261.
- 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 CH6001 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 23 inclusion and 36 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 26 Jan 2023. 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?
Area under the Curve (AUC) of total plasma CHF6001 (time frame: Over 240 hours after CHF6001 administration). 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?
On the ClinicalTrials.gov record for NCT05431426, which also lists 1 linked publication.
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 26 Jan 2023.