Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348555
• Other study ID #: V00162 PI 101 1A
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 13, 2011
• Last updated: June 3, 2013
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2011
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Health Products Safety Agency_AFSSAPS
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria Part A:

• 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.

Inclusion Criteria Part B:

• 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.

Exclusion Criteria Part A:

• 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,

Exclusion Criteria Part B:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Bronchodilatator

• Bronchodilatator

Locations

Country	Name	City	State
Belgium	SGS	Anvers
France	SGS Aster SAS	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Fabre Medicament	SGS Life Science Services

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the local tolerability of V0162 in healthy male volunteers	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).	change from baseline in the local tolerability over 72 h after dosing	Yes
Secondary	To determine the PK parameters of V0162 in healthy male volunteers	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.	0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing	Yes
Secondary	To assess the bronchodilator properties of V0162 in COPD	Monitoring of parameters of the pulmonary function through plethysmography measurements.	0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing	Yes