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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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. )

Tracking Information
First Submitted Date  ICMJE December 9, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date August 31, 2015
Study Start Date  ICMJE March 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
FEV1 AUC0-12h [ Time Frame: Baseline, 12 hours ]
baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02315131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • FEV1 [ Time Frame: Baseline, 12 hours ]
    baseline adjusted trough 12 hour
  • Percentage of Participants with Adverse Events [ Time Frame: 28 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Healthy Volunteers and COPD Patients to Evaluate the Efficacy and Safety of Inhaled TV46017
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo Comparator
    Other Name: Matching placebo
Study Arms  ICMJE
  • Experimental: TV46017- Healthy Volunteers
    Stage 1 includes a single-dose treatment period
    Intervention: Drug: TV46017
  • Placebo Comparator: Placebo - Healthy Volunteers
    Some healthy subjects will be randomized to receive placebo.
    Intervention: Drug: 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
    Intervention: Drug: TV46017
  • Experimental: TV46017 60 μg- COPD
    Stage 2
    Intervention: Drug: TV46017
  • Experimental: TV46017 120 μg- COPD
    Stage 2
    Intervention: Drug: TV46017
  • Experimental: TV46017 240 μg- COPD
    Stage 2
    Intervention: Drug: TV46017
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 27, 2015)
53
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
140
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02315131
Other Study ID Numbers  ICMJE TV46017-COPD-10046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Study Sponsor  ICMJE Teva Branded Pharmaceutical Products, R&D Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
PRS Account Teva Pharmaceutical Industries
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP