Chronic Obstructive Pulmonary Disease (COPD
Conditions
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
Interventions
DRUGTV46017
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.
DRUGPlacebo
Placebo Comparator
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 AUC0-12h | Baseline, 12 hours | baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | Baseline, 12 hours | baseline adjusted trough 12 hour |
| Percentage of Participants with Adverse Events | 28 Days | — |
Countries
Australia, New Zealand, United States
Outcome results
None listed