Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

This study has been completed.
Sponsor:
Collaborator:
SGS Life Science Services
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01348555
First received: April 13, 2011
Last updated: June 3, 2013
Last verified: May 2011
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Bronchodilatator
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing ] [ Designated as safety issue: Yes ]
    Monitoring of parameters of the pulmonary function through plethysmography measurements.


Enrollment: 108
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V0162 Drug: Bronchodilatator
Placebo Comparator: Placebo Drug: Bronchodilatator

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348555

Locations
Belgium
SGS
Anvers, Belgium
France
SGS Aster SAS
Paris, France
Sponsors and Collaborators
Pierre Fabre Medicament
SGS Life Science Services
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01348555     History of Changes
Other Study ID Numbers: V00162 PI 101 1A
Study First Received: April 13, 2011
Last Updated: June 3, 2013
Health Authority: France: French Health Products Safety Agency_AFSSAPS

Keywords provided by Pierre Fabre Medicament:
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014