Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

Pierre Fabre

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Bronchodilatator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01348555

V00162 PI 101 1A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

V0162

Experimental group

Treatment:

Drug: Bronchodilatator

Drug: Bronchodilatator

Placebo

Placebo Comparator group

Treatment:

Drug: Bronchodilatator

Drug: Bronchodilatator