NCT01348555

Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Bronchodilatator
DRUG	Bronchodilatator

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-05-05
• Last updated: 2013-06-04

Locations

2 sites across 2 countries: Belgium, France