PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers

NCT05431426 | Completed Phase 1

• 2 other identifiers: CLI-06001AA1-072021-005567-43
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Renal impairment

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Over 240 hours after CHF6001 administration

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 240 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 renal impaired subjects

EXPERIMENTAL

Administration of a single dose of CH6001 800 µg in mild renal impaired subjects.

Drug: CH6001

Moderate renal impaired subjects

EXPERIMENTAL

Administration of a single dose of CH6001 800 µg in moderate renal impaired subjects.

Drug: CH6001

Severe renal impaired subjects

EXPERIMENTAL

Administration of a single dose of CH6001 800 µg in severe renal impaired subjects.

Drug: CH6001

Healthy volunteers

EXPERIMENTAL

Administration of a single dose of CH6001 800 µg in healthy volunteers.

Drug: CH6001

Interventions

CH6001 DRUG

CHF6001 will be administered using the NEXThaler® DPI device

Healthy volunteers; Mild renal impaired subjects; Moderate renal impaired subjects; Severe renal impaired 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;
• 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;
• 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:
• a. 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

MC Comac Medical Ltd.

Sofia, 1612, 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; Renal Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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 31, 2022
• First Posted: June 24, 2022
• Study Start: July 29, 2022
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)