An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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 TV48108

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02315144
• Other study ID #: TV48108-COPD-10045
• Status: Terminated
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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 a1 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• TV48108
TV48108 15, 60, 120 µg
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
Australia	Teva Investigational Site 78992	Clayton
Australia	Teva Investigational Site 78993	Daws Park
Australia	Teva Investigational Site 78991	Melbourne
New Zealand	Teva Investigational Site 79041	Auckland
New Zealand	Teva Investigational Site 79040	Christchurch
United States	Teva Investigational Site 13038	Medford	Oregon
United States	Teva Investigational Site 13039	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)		Day 1 (pre-dose, up to 12 hours post-dose)
Secondary	Percentage of Participants with Adverse Events		28 Days