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Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

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ClinicalTrials.gov Identifier: NCT01348555
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : June 4, 2013
Sponsor:
Collaborator:
SGS Life Sciences
Information provided by (Responsible Party):
Pierre Fabre Medicament

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Bronchodilatator Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: V0162 Drug: Bronchodilatator
Placebo Comparator: Placebo Drug: Bronchodilatator



Primary Outcome Measures :
  1. To assess the local tolerability of V0162 in healthy male volunteers [ Time Frame: change from baseline in the local tolerability over 72 h after dosing ]

    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 :
  1. To determine the PK parameters of V0162 in healthy male volunteers [ Time Frame: 0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing ]
    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.

  2. To assess the bronchodilator properties of V0162 in COPD [ Time Frame: 0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing ]
    Monitoring of parameters of the pulmonary function through plethysmography measurements.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348555


Locations
Belgium
SGS
Anvers, Belgium
France
SGS Aster SAS
Paris, France
Sponsors and Collaborators
Pierre Fabre Medicament
SGS Life Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01348555     History of Changes
Other Study ID Numbers: V00162 PI 101 1A
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: May 2011

Keywords provided by Pierre Fabre Medicament:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases