NCT02315131

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo Comparator

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-12-11
• Last updated: 2021-11-09

Locations

7 sites across 3 countries: United States, Australia, New Zealand