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

NCT ID: NCT02315131

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-08-31

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

TV46017- Healthy Volunteers

Stage 1 includes a single-dose treatment period

Group Type: EXPERIMENTAL

TV46017

Intervention Type: DRUG

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.

Placebo - Healthy Volunteers

Some healthy subjects will be randomized to receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Comparator

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

Group Type: EXPERIMENTAL

TV46017

Intervention Type: DRUG

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.

TV46017 60 μg- COPD

Stage 2

Group Type: EXPERIMENTAL

TV46017

Intervention Type: DRUG

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.

TV46017 120 μg- COPD

Stage 2

Group Type: EXPERIMENTAL

TV46017

Intervention Type: DRUG

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.

TV46017 240 μg- COPD

Stage 2

Group Type: EXPERIMENTAL

TV46017

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo Comparator

Intervention Type: DRUG

Other Intervention Names

46017; Matching placebo

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 13033

St Louis, Missouri, United States

Teva Investigational Site 13034

Raleigh, North Carolina, United States

Teva Investigational Site 78984

Adelaide, , Australia

Teva Investigational Site 78985

Nedlands, , Australia

Teva Investigational Site 79037

Auckland, , New Zealand

Teva Investigational Site 79036

Hamilton, , New Zealand

Teva Investigational Site 79034

Wellington, , New Zealand

Countries

United States; Australia; New Zealand

Other Identifiers

TV46017-COPD-10046

Identifier Type: -

Identifier Source: org_study_id