Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
Recruitment status was Recruiting
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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 |
- 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).
- 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.
| Estimated Enrollment: | 92 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | March 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 |
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| France | |
| SGS Aster SAS | Recruiting |
| Paris, France | |
| Contact: Philippe Betting, MD 00(33)15368 ext 0868 | |
| Principal Investigator: Philippe Betting, MD | |
| Sub-Investigator: Thomas Similowski, MD | |
| Sub-Investigator: Philippe Devillier, MD | |
| Sub-Investigator: Eric Garrigue, MD | |
More Information
No publications provided
| Responsible Party: | Thierry Clerc, Project Director, 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: | May 4, 2011 |
| Health Authority: | France: French Health Products Safety Agency_AFSSAPS |
Keywords provided by Pierre Fabre Medicament:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders 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 May 19, 2013