NCT02359292

Completed

Phase 1

Cross-over Clinical Pharmacology Study, to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination Across Two Different Dose Strengths, Administered With and Without Activated Charcoal, in Healthy Volunteers

Chiesi Farmaceutici S.p.A.1 site in 1 country50 target enrollmentFebruary 2015

ConditionsAsthma

InterventionsCHF 5993 HS 200/6/25 pMDI CHF 5993 MS 100/6/25 pMDI CHF 5993 HS 200/6/25 pMDI + Charcoal Block CHF 5993 MS 100/6/25 pMDI + Charcoal Block Placebo pMDI

DrugsCHF 5993 HS 200/6/25 pMDI CHF 5993 MS 100/6/25 pMDI CHF 5993 HS 200/6/25 pMDI + Charcoal Block CHF 5993 MS 100/6/25 pMDI + Charcoal Block Placebo pMDI

Overview

Phase: Phase 1
Intervention: CHF 5993 HS 200/6/25 pMDI
Conditions: Asthma
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 50
Locations: 1
Primary Endpoint: Systemic exposure of B17MP, Formoterol and Glycopyrronium bromide, without charcoal block (To evaluate the total systemic exposure as AUCt and Cmax) Composite outcome measures of PK variables
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is performed to evaluate the total systemic exposure and lung bioavailability of CHF 5993 pMDI combination, in healthy volunteers subjects.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

July 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chiesi Farmaceutici S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject's written informed consent obtained prior to any study related procedure.
•Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
•Male and female subjects aged 18 to 55 years inclusive.
•Body mass index (BMI) within the range of 18 to 30 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.
•Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and before randomization.
•Lung function measurements within normal limits (Normal values (according to GINA 2014 document): FEV1/FVC \> 0.70 and FEV1 \> 80% predicted).
•Male subjects: they and/or their partner must be willing to use an approved method of contraception from the time of screening and until 30 days after the last dose of study. Subjects must not donate sperm for 30 days after the last dose of study drug.\*
•Female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential (defined as all women physiologically capable of becoming pregnant), using an acceptable method of contraception
•Surgical sterilization (i.e. bilateral tubal ligation, hysterectomy for females; vasectomy for males)

Exclusion Criteria

•Blood donation (equal or more than 450 ml) or blood loss, less than 8 weeks before inhalation of the study medication.
•Female subjects: pregnant or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of the gestation) confirmed by a positive urine test at screening and randomization.
•Positive HIV1 or HIV2 serology.
•Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C.
•Unsuitable veins for repeated venipuncture.
•History of alcohol abuse within 12 months prior to screening.
•History of drug abuse within 12 months prior to screening (or positive urine drug test performed at screening).
•Subjects who have a positive urine test for cotinine.
•Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation. Note: In case of abnormal laboratory values, the test can be performed again once before randomization.
•Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.

Arms & Interventions

CHF 5993 HS 200/6/25 pMDI

High Strength fixed combination

Intervention: CHF 5993 HS 200/6/25 pMDI

CHF 5993 MS 100/6/25 pMDI

Medium Strength fixed combination

Intervention: CHF 5993 MS 100/6/25 pMDI

CHF 5993 HS 200/6/25 pMDI + Charcoal Block

High Strength fixed combination plus Charcoal Block

Intervention: CHF 5993 HS 200/6/25 pMDI + Charcoal Block

CHF 5993 MS 100/6/25 pMDI + Charcoal Block

Medium Strength fixed combination plus Charcoal Block

Intervention: CHF 5993 MS 100/6/25 pMDI + Charcoal Block

Placebo pMDI

Placebo

Intervention: Placebo pMDI

Outcomes

Primary Outcomes

Systemic exposure of B17MP, Formoterol and Glycopyrronium bromide, without charcoal block (To evaluate the total systemic exposure as AUCt and Cmax) Composite outcome measures of PK variables

Time Frame: over 32hours after administration

Composite outcome measures of PK variables

Lung exposure of B17MP, Formoterol and Glycopyrronium bromide without charcoal block (To evaluate the lung exposure (as AUCt and Cmax) Composite outcome measures of PK variables

Time Frame: over 32hours after administration

Composite outcome measures of PK variables

Secondary Outcomes

Systemic effects of CHF5993 (To evaluate the systemic effects as potassium and glucose levels) Composite outcome measures of PD variables(over 24hours after administration)
Systemic cardiac effects and the general safety (Composite outcome measures of cardiac variables (such as HR, BP, QT) and safety variables (such as AE, SAE)(over 24hours after administration)