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Study in Healthy Volunteers and COPD Patients to Evaluate the Efficacy and Safety of Inhaled TV46017

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ClinicalTrials.gov Identifier: NCT02315131
Recruitment Status : Terminated (Business decision)
First Posted : December 11, 2014
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV46017

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD Drug: TV46017 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A 2-Stage, Single-Dose Study in Healthy Volunteers and COPD Patients With an Open Label Ipratropium Bromide Reference to Evaluate the Efficacy, Pharmacokinetics, and Safety Profile of Inhaled TV46017
Study Start Date : March 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: TV46017- Healthy Volunteers
Stage 1 includes a single-dose treatment period
Drug: TV46017
TV46017 15, 60, 120, and 240 μg; 4 ascending doses of inhaled TV46017 with an ipratropium bromide reference to evaluate the single administration of 4 ascending doses of inhaled TV46017 in COPD patients.
Other Name: 46017

Placebo Comparator: Placebo - Healthy Volunteers
Some healthy subjects will be randomized to receive placebo.
Drug: Placebo
Placebo Comparator
Other Name: Matching placebo

Experimental: TV46017 15 μg- COPD
Stage 2 includes two 24 hour treatment periods with approximately 7 days of washout in between each treatment period; and open label ipratropium bromide pressurized metered-dose inhaler hydrofluoroalkane (HFA) will be administered
Drug: TV46017
TV46017 15, 60, 120, and 240 μg; 4 ascending doses of inhaled TV46017 with an ipratropium bromide reference to evaluate the single administration of 4 ascending doses of inhaled TV46017 in COPD patients.
Other Name: 46017

Experimental: TV46017 60 μg- COPD
Stage 2
Drug: TV46017
TV46017 15, 60, 120, and 240 μg; 4 ascending doses of inhaled TV46017 with an ipratropium bromide reference to evaluate the single administration of 4 ascending doses of inhaled TV46017 in COPD patients.
Other Name: 46017

Experimental: TV46017 120 μg- COPD
Stage 2
Drug: TV46017
TV46017 15, 60, 120, and 240 μg; 4 ascending doses of inhaled TV46017 with an ipratropium bromide reference to evaluate the single administration of 4 ascending doses of inhaled TV46017 in COPD patients.
Other Name: 46017

Experimental: TV46017 240 μg- COPD
Stage 2
Drug: TV46017
TV46017 15, 60, 120, and 240 μg; 4 ascending doses of inhaled TV46017 with an ipratropium bromide reference to evaluate the single administration of 4 ascending doses of inhaled TV46017 in COPD patients.
Other Name: 46017




Primary Outcome Measures :
  1. FEV1 AUC0-12h [ Time Frame: Baseline, 12 hours ]
    baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours


Secondary Outcome Measures :
  1. FEV1 [ Time Frame: Baseline, 12 hours ]
    baseline adjusted trough 12 hour

  2. Percentage of Participants with Adverse Events [ Time Frame: 28 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Stage 1 Inclusion Criteria (healthy volunteers):

  • The subject is a male or female 20 to 75 years of age, inclusive, weighing 50 to 80 kg with a body mass index (BMI) of less than 30 kg/m2. Note: Every effort should be made to enroll approximately equal numbers of men and women in each group.
  • The subject is in good health as determined by medical and psychiatric history, physical examination, electrocardiogram (ECG), serum chemistry, hematology, urinalysis, and serology.
  • Other criteria apply, please contact the investigator for more information

Stage 2 Inclusion Criteria (COPD patients):

  • Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the SV (number of cigarette packs smoked per day multiplied by the number of years smoked; eg, 2 packs/day for 3 years equals a 6 pack year history).
  • Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines.
  • Male or female; 40 to 75 years of age, inclusive.
  • Patient is free of any other medical conditions or concomitant treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
  • Other criteria apply, please contact the investigator for more information

Stage 1 Exclusion Criteria (healthy volunteers):

  • History or current evidence of a clinically significant or uncontrolled disease.
  • Any disorder that may interfere with the absorption, distribution, metabolism or excretion of study drugs.
  • History of severe allergy to milk protein.
  • Active smokers or former smokers who quit within 3 months of the first dose of study drug. Former smokers with greater than five-pack years (ie, the equivalent of one pack per day for five years) are also excluded.
  • Other criteria apply, please contact the investigator for more information

Stage 2 Exclusion Criteria (COPD patients):

  • Recent history of hospitalization due to an exacerbation of airway disease within 3 months.
  • Need for increased treatments of COPD within 6 weeks prior to the SV.
  • Occurrence of a COPD exacerbation, which is not resolved by 4 weeks or more prior to the SV/informed consent. (Note: An exacerbation of COPD is defined as any worsening of the patient's baseline COPD symptoms requiring any treatment other than rescue albuterol or the patient's regular maintenance therapy. This includes requiring the use of systemic corticosteroids, antibiotics, and/or emergency room visit or hospitalization.)
  • History of and/or current diagnosis of asthma.
  • Known α1 antitrypsin deficiency, active lung infections (such as tuberculosis or pneumonia), and lung cancer are absolute exclusionary conditions. A patient who, in the opinion of the investigator, has any other significant respiratory condition in addition to COPD should be excluded. Examples may include clinically significant noncystic bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Allergic rhinitis is not exclusionary.
  • Other criteria apply, please contact the investigator for more information

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): NCT02315131


Locations
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United States, Missouri
Teva Investigational Site 13033
Saint Louis, Missouri, United States
United States, North Carolina
Teva Investigational Site 13034
Raleigh, North Carolina, United States
Australia
Teva Investigational Site 78984
Adelaide, Australia
Teva Investigational Site 78985
Nedlands, Australia
New Zealand
Teva Investigational Site 79037
Auckland, New Zealand
Teva Investigational Site 79036
Hamilton, New Zealand
Teva Investigational Site 79034
Wellington, New Zealand
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02315131     History of Changes
Other Study ID Numbers: TV46017-COPD-10046
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Ipratropium
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action