Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

NCT ID: NCT01348555

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

V0162

Group Type: EXPERIMENTAL

Bronchodilatator

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Bronchodilatator

Intervention Type: DRUG

Interventions

Bronchodilatator

Intervention Type: DRUG

Bronchodilatator

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

SGS Life Sciences, a division of SGS Belgium NV

OTHER

Sponsor Role: collaborator

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SGS

Antwerp, , Belgium

SGS Aster SAS

Paris, , France

Countries

Belgium; France

References

Devillier P, Garrigue E, D'Auzers G, Monjotin N, Similowski T, Clerc T. V0162 a new long-acting bronchodilator for treatment of chronic obstructive lung diseases: preclinical and clinical results. Respir Res. 2015 Jun 8;16(1):68. doi: 10.1186/s12931-015-0227-1.

Reference Type: DERIVED

PMID: 26050967 (View on PubMed)

Other Identifiers

V00162 PI 101 1A

Identifier Type: -

Identifier Source: org_study_id