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Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Bronchodilatator

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

SGS
SGS Aster SAS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V0162

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

To assess the bronchodilator properties of V0162 in COPD

Monitoring of parameters of the pulmonary function through plethysmography measurements.

Full Information

NCT ID

NCT01348555

First Posted

April 13, 2011

Last Updated

June 3, 2013

Sponsor

Pierre Fabre Medicament

Collaborators

SGS Life Sciences, a division of SGS Belgium NV

1. Study Identification

Unique Protocol Identification Number

NCT01348555

Brief Title

Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pierre Fabre Medicament

Collaborators

SGS Life Sciences, a division of SGS Belgium NV

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V0162

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Bronchodilatator

Intervention Type

Drug

Intervention Name(s)

Bronchodilatator

Primary Outcome Measure Information:

Title

To assess the local tolerability of V0162 in healthy male volunteers

Description

Time Frame

change from baseline in the local tolerability over 72 h after dosing

Secondary Outcome Measure Information:

Title

To determine the PK parameters of V0162 in healthy male volunteers

Description

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.

Time Frame

0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing

Title

To assess the bronchodilator properties of V0162 in COPD

Description

Monitoring of parameters of the pulmonary function through plethysmography measurements.

Time Frame

0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

SGS

City

Anvers

Country

Belgium

Facility Name

SGS Aster SAS

City

Paris

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

26050967

Citation

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.

Results Reference

derived

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Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

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