An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients
Phase 1
Terminated
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT02315144
- Lead Sponsor
- 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 TV48108.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
Stage 1 (Healthy Volunteers)
- 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/m^2.
- 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 (Chronic Obstructive Lung Disease (COPD) patients)
- Male or female; 40 to 75 years of age, inclusive with a minimum body weight of 40 kg
- Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the screening visit
- Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines.
- Other criteria apply, please contact the investigator for more information
Exclusion Criteria
Stage 1 (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 (Chronic Obstructive Lung Disease (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 screening visit
- 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
- Other criteria apply, please contact the investigator for more information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo - Healthy Volunteers Placebo Placebo TV48108 60 µg COPD TV48108 Stage 2 TV48108 120 µg COPD TV48108 Stage 2 . TV48108 - Healthy Volunteers TV48108 Stage 1 is a randomized, placebo-controlled, double-blind, single-dose study. Healthy subjects will be randomized to receive a single inhaled dose of TV48108 120 µg TV48108 15 µg COPD TV48108 Stage 2 consists of a 2-period open-label study with an ipratropium bromide reference to evaluate the single administration of 3 ascending doses of inhaled TV48108 in COPD patients.
- Primary Outcome Measures
Name Time Method Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h). Day 1 (pre-dose, up to 12 hours post-dose)
- Secondary Outcome Measures
Name Time Method Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1) Day 1 (pre-dose, up to 12 hours post-dose) Percentage of Participants with Adverse Events 28 Days
Trial Locations
- Locations (7)
Teva Investigational Site 13038
🇺🇸Medford, Oregon, United States
Teva Investigational Site 13039
🇺🇸Spartanburg, South Carolina, United States
Teva Investigational Site 78993
🇦🇺Daws Park, Australia
Teva Investigational Site 78992
🇦🇺Clayton, Australia
Teva Investigational Site 78991
🇦🇺Melbourne, Australia
Teva Investigational Site 79041
🇳🇿Auckland, New Zealand
Teva Investigational Site 79040
🇳🇿Christchurch, New Zealand