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
Overview
- Phase
- Phase 1
- Intervention
- TV46017
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 53
- Locations
- 7
- Primary Endpoint
- FEV1 AUC0-12h
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TV46017- Healthy Volunteers
Stage 1 includes a single-dose treatment period
Intervention: TV46017
Placebo - Healthy Volunteers
Some healthy subjects will be randomized to receive placebo.
Intervention: Placebo
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: TV46017
TV46017 60 μg- COPD
Stage 2
Intervention: TV46017
TV46017 120 μg- COPD
Stage 2
Intervention: TV46017
TV46017 240 μg- COPD
Stage 2
Intervention: TV46017
Outcomes
Primary Outcomes
FEV1 AUC0-12h
Time Frame: Baseline, 12 hours
baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours
Secondary Outcomes
- FEV1(Baseline, 12 hours)
- Percentage of Participants with Adverse Events(28 Days)