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Keep this study
Lead
Pierre Fabre Medicament
With
SGS Life Sciences, a division of SGS Belgium NV
This study has two parts. Part A will be conducted in 72 healthy volunteers. Part B will be conducted in 20 patients diagnosed with COPD.
Part A The primary objective of this part of the study is to assess the local tolerability of escalating doses of V0162 in male healthy volunteers.
Part B The primary objective of this part of the study is to assess the bronchodilator properties of V0162 at the maximal tolerated dose (determined in Part A) in COPD patients.
In addition, pharmacokinetics and vital sign including ECG will be determined.
Age
18–65
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Male gender
Age between 18 to 50 years included,
18 ≤ Body Mass Index (BMI) \< 30 kg/m²,
Who had given their written consent for their participation in the study,
Who, in the judgement of the Investigator, are likely to be compliant during the study,
Registered with a social security insurance system.
Aged 40 to 65 years-old,
18 ≤ BMI \< 35 kg/m2,
Smokers ≥ 10 packs / year,
Moderate to severe COPD
Registered with a social security insurance system.
You may not be if
History of asthma or significant respiratory disorder,
History of allergic rhinitis,
Upper respiratory tract infection in the last month,
Blood eosinophil count ≥ 600/μL,
Epilepsy, narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction,
Abnormal spirography,
Respiratory tract infection in the last 6 weeks,
Asthma or significant respiratory disorder other than COPD,
Allergic rhinitis,
Blood eosinophil count ≥ 600/μL,
Epilepsy, narrow angle glaucoma, moderate to severe prostatic hypertrophy or bladder neckobstruction,
Myocardial infarction within the previous 6 months, heart failure or serious cardiac arrhythmia,
Moderate to severe renal impairment,
Moderate to severe hepatic impairment
Use of short-acting b-agonist,
Use of anticholinergics
Clareo Health | Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
