Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Dos

• Status: Recruiting
• Trial end date: 2023-08-03
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to compare the pharmacokinetic (PK) of BDP (and its main active metabolite B17MP), FF, and GB between CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI and CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI (pressurized Metered Dose Inhaler), to assess the proportionality of systemic exposure to BDP and B17MP (17-Monoproprionate), and the systemic exposure to FF and GB with increasing doses of BDP.

The study includes a QVAR REDIHALER® arm too.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Collaborator: SGS S.A.
• Treatments: Beclomethasone

Criteria

Inclusion Criteria:

• Subject's written informed consent ;

• 18-55 years of age;

• Ability to understand the study procedures, the risks involved and ability to be trained to correctly use the inhalers.

• Body mass index of 19.0 to 30.0 kg/m2 (extremes inclusive), and body weight ≥50.0 kg;

• Non- or ex-smokers who smoked <5 pack-years and stopped smoking >1 year prior to screening;

• Good physical and mental status, determined based on the medical history and a general clinical examination;

• Vital signs within normal limits at screening: diastolic blood pressure (DBP) 40 to 90 mmHg, systolic blood pressure (SBP) 90 to 140 mmHg

• 12-Lead digitised electrocardiogram (ECG) in triplicate considered as normal (40 ≤ heart rate [HR] ≤110 beats per minute, 120 milliseconds [ms] ≤ PR interval [PR] ≤220 ms [PR ≤120 ms without a delta wave may be acceptable], QRS interval [QRS] ≤120 ms, and Fridericia corrected QT interval [QTcF] ≤450 ms for males and QTcF ≤470 ms for females).

• Lung function measurements within normal limits at screening: forced expiratory volume in the first second (FEV1) equal to or more than 80% of predicted for the subject's normal value according to the Global Lung Function Initiative, European Respiratory Society Task Force Lung Function Reference Values and FEV1/forced vital capacity ratio >0.70.

• Female subjects of non-chid bearing potential or females of childbearing potential with a negative pregnancy test and acceptable contraceptive methods.

Exclusion Criteria:

• Participation in another clinical study with an investigational drug in the 30 days or five half-lives of that investigational drug (whichever is longer) preceding the administration of the study treatment; longer and more appropriate time could be considered by the Investigator based on the terminal half-life (t1/2) and/or long-term toxicity of the previous investigational drug;

• Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic or psychiatric disorders that may interfere with successful completion of this protocol according to the Investigator's judgment;

• Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);

• Positive urine test for cotinine.

• Intake of non-permitted concomitant medications in the predefined period prior to screening, or prior to randomisation or the subject is expected to take non-permitted concomitant medications during the study;

• Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or prior to randomisation;

• Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;

• Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would prevent use of anticholinergics;

• For females only: pregnant or lactating women.

• Subjects receiving treatment with any drug known to have a well defined potential for hepatotoxicity.

• Subjects using e-cigarettes within 6 months before screening.

Other Inclusion/exclusion criteria as defined by the protocol.