Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
Pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (COPD) management to reduce morbidity, disability and mortality. To date, the recommended treatment of moderate to severe COPD patients consist in the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a medical need in new product that could exhibit both anti-inflammatory and strong bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.
Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound and could bring new option in the treatment of this life-threatening disease.
Chronic Obstructive Pulmonary Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- To assess the local tolerability of V0162 in healthy male volunteers [ Time Frame: change from baseline in the local tolerability over 72 h after dosing ] [ Designated as safety issue: Yes ]
Monitoring of parameters of the pulmonary function: spirometry measurements. Assessment of respiratory system symptoms: using a 4-point scale and assessment of dyspnoea by VAS. Monitoring for the occurrence of AEs.
Changes in physical examination: vital signs (blood pressure and pulse rate), holter-ECG and clinical laboratory tests (biochemistry, haematology, urinalysis).
- To determine the PK parameters of V0162 in healthy male volunteers [ Time Frame: 0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing ] [ Designated as safety issue: Yes ]Pharmacokinetics: evaluation of the PK parameter of V0162 (measured by area under the plasma concentration-time curve (AUC)) after oral administration and of the dose proportionality.
- To assess the bronchodilator properties of V0162 in COPD [ Time Frame: 0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing ] [ Designated as safety issue: Yes ]Monitoring of parameters of the pulmonary function through plethysmography measurements.
|Study Start Date:||April 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: V0162||Drug: Bronchodilatator|
|Placebo Comparator: Placebo||Drug: Bronchodilatator|
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.