Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Bronchodilatator

• Registration Number: NCT01348555
• Lead Sponsor: Pierre Fabre Medicament

Brief 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-13
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
V0162	Bronchodilatator	-
Placebo	Bronchodilatator	-

Primary Outcome Measures

Name	Time	Method
To assess the local tolerability of V0162 in healthy male volunteers	change from baseline in the local tolerability over 72 h after dosing	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).

Secondary Outcome Measures

Name	Time	Method
To determine the PK parameters of V0162 in healthy male volunteers	0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing	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	0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing	Monitoring of parameters of the pulmonary function through plethysmography measurements.

Trial Locations

Locations (2)

SGS; 🇧🇪 Anvers, Belgium

SGS Aster SAS; 🇫🇷 Paris, France