Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.
Detailed description
The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part. Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.
Interventions
DRUGCHF 6001 SD or placebo
Dry Powder Inhaler
DRUGCHF 6001 MD or placebo
Dry Powder Inhaler
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject's written informed consent obtained prior to any study-related procedure * Male healthy volunteers aged 18-55 years; * Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly. * Body Mass Index (BMI) between 18.0 and 28.0 kg/m2; * 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; * Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator. * A reliable method of contraception for the subjects and their partner.
Exclusion criteria
* Blood donation or blood loss less than 8 weeks before inhalation of the study medication; * Positive HIV1 or HIV2 serology; * Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C; * History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening; * Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation; * Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol; * Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole). * Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre. * Heavy caffeine drinker (\> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | After 7 days of treatment | — |
| Adverse events, adverse drug reactions, serious adverse events. | After 7 days of treatment | The number and percentage of subjects with adverse events, adverse drug reactions, serious adverse events |
| Vital signs | After 7 days of treatment | Blood pressure and Heart rate |
| 12-lead ECG | After 7 days of treatment | Heart rate, RR, PR, QRS, QT, QTcB, QTcF |
| 24h ECG Holter | After 7 days of treatment | Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..) |
| FEV1 | After 7 days of treatment | — |
| Blood and urine Laboratory tests | After 7 days of treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of CHF 6001 and its metabolite | After 7 days of treatment | AUC; Cmax and tmax; t½ |
Countries
United Kingdom
Outcome results
None listed