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

Phase 1

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease (COPD
• Interventions: Drug: TV46017; Drug: Placebo

• Registration Number: NCT02315131
• 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 TV46017

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-11
• Study Start: 2015-03
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TV46017- Healthy Volunteers	TV46017	Stage 1 includes a single-dose treatment period
TV46017 15 μg- COPD	TV46017	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
Placebo - Healthy Volunteers	Placebo	Some healthy subjects will be randomized to receive placebo.
TV46017 240 μg- COPD	TV46017	Stage 2
TV46017 120 μg- COPD	TV46017	Stage 2
TV46017 60 μg- COPD	TV46017	Stage 2

Primary Outcome Measures

Name	Time	Method
FEV1 AUC0-12h	Baseline, 12 hours	baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours

Secondary Outcome Measures

Name	Time	Method
FEV1	Baseline, 12 hours	baseline adjusted trough 12 hour
Percentage of Participants with Adverse Events	28 Days

Trial Locations

Locations (7)

Teva Investigational Site 78984; 🇦🇺 Adelaide, Australia

Teva Investigational Site 13033; 🇺🇸 Saint Louis, Missouri, United States

Teva Investigational Site 13034; 🇺🇸 Raleigh, North Carolina, United States

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