Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

NCT01348555 | Completed Phase 1 DMC

• 1 other identifier: V00162 PI 101 1A
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

V0162

EXPERIMENTAL

Drug: Bronchodilatator

Placebo

PLACEBO COMPARATOR

Drug: Bronchodilatator

Interventions

Bronchodilatator DRUG

V0162

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male gender
• Age between 18 to 50 years included,
• ≤ 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,
• ≤ BMI \< 35 kg/m2,
• Smokers ≥ 10 packs / year,
• Moderate to severe COPD
• Registered with a social security insurance system.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Pierre Fabre Medicament: lead
• SGS Life Sciences, a division of SGS Belgium NV: collaborator

Study Sites (2)

SGS

Antwerp, Belgium

Location

SGS Aster SAS

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 26050967 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: May 5, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 4, 2013

Record last verified: 2011-05

Locations

FR (1); BE (1)