Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control Subjects

NCT05373953 | Completed Phase 1

• 2 other identifiers: CLI-06001AA1-082021-003729-31
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial to investigate the pharmacokinetics, safety and tolerability of CHF6001 after single administrations in participants with mild, moderate and severe liver impairment with matched healthy adult volunteers

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic parameter (Cmax)

  Peak Plasma Concentration (Cmax) for CHF6001 for total plasma

  Over 240 hours after administration in blood

• Pharmacokinetic parameter (AUCt)

  Area under the plasma concentration versus time curve (AUCt) for CHF6001 for total plasma

  Over 240 hours after administration in blood

Secondary Outcomes (10)

• Pharmacokinetic parameter ( Cmax)

  Over 240 hours after administration in blood

• Pharmacokinetic parameter (AUCt)

  Over 240 hours after administration in blood

• Pharmacokinetic parameter (AUC0-72)

  Over 72 hours after administration in blood

• Pharmacokinetic parameter (AUC0-240)

  Over 240 hours after administration in blood

• Pharmacokinetic parameter (AUC0-∞)

  Over 240 hours after administration in blood

Study Arms (4)

mild impairment subjects

EXPERIMENTAL

Administration of a single dose of CHF6001 800 µg in mild impairment subjects

Drug: CHF6001

moderate impairment subjects

EXPERIMENTAL

Administration of a single dose of CHF6001 800 µg in moderate impairment subjects

Drug: CHF6001

severe impairment subjects

EXPERIMENTAL

Administration of a single dose of CHF6001 800 µg in severe impairment subjects

Drug: CHF6001

healthy volunteers

ACTIVE COMPARATOR

Administration of a single dose of CHF6001 800 µg in healthy volunteers

Drug: CHF6001

Interventions

CHF6001 DRUG

CHF6001 will be administered using the NEXThaler® DPI device

healthy volunteers; mild impairment subjects; moderate impairment subjects; severe impairment subjects

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects:
• Subject's written informed consent obtained prior to any study-related procedure;
• Ability to understand the study procedures and the risks involved, and ability to be rained to use the inhalers correctly and to generate sufficient peak inspiratory flow (PIF; at least 40 L/min) using the In- Check DIAL set as per NEXThaler® inhaler resistance;
• Lead digitised electrocardiogram (ECG) in triplicate considered as normal (40 beats per minute \[bpm\] ≤ 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) at screening visit. The mean value must be within the defined range;
• Male and female subjects aged 40 to 80 years inclusive;
• Subjects must weigh at least 45 kg for females and 50 kg for males to participate in the study, and must have a body mass index 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;
• Female subjects: a. 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 at least an acceptable effective birth control method from the signature of the informed consent and until study discontinuation; 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 (i.e. post-menopausal or permanently sterile. Tubal ligation or partial surgical interventions are not acceptable.
• Vital signs within normal limits at screening: diastolic blood pressure (DBP) 40-89 mmHg and systolic blood pressure (SBP) 90-139 mmHg, extremes included (two measures performed after at least 5 minutes of resting).
• Body temperature \< 37.5°C at screening and prior to study treatment administration;
• 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;
• Healthy subjects only:
• Good mental and physical status, determined on the basis of the medical history and a general clinical examination, at screening and prior to study treatment administration;
• Matched to at least one liver impaired subject enrolled in the study with respect to race, gender, age (±10 years) and body weight (±15%)
• Liver impaired subjects only:

You may not qualify if:

• All subjects:
• 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 prior to study treatment administration;
• Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);
• Positive human immunodeficiency virus (HIV) 1 or HIV2 serology at screening;
• Subject has pre-planned surgery or procedures that would interfere with the conduct of the study;
• Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks, or complications from this disease, which has not resolved within 14 days prior to screening or prior to study treatment administration;
• Blood donation or blood loss (≥ 450 mL) less than 2 months prior to screening or prior to study treatment administration;
• Abnormal haemoglobin level defined as \< 13 g/dL for males and \< 11 g/dL for females at screening;
• Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen evaluated at screening or prior to study treatment administration;
• Intake of non-permitted concomitant medications in the predefined period prior to screening or prior to study treatment administration, or the subject is expected to take non-permitted concomitant medications during the study
• Unsuitable veins for repeated venepuncture;
• Participation in another clinical study where an investigational treatment was received, and last investigations were performed less than 8 weeks prior to screening;
• Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or to study treatment administration;
• Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
• 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);

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

MC Comac Medical Ltd.

Sofia, 1618, Bulgaria

Location

Related Publications (1)

• 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.

  PMID: 40391696 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tanimilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 13, 2022
• Study Start: May 5, 2022
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)