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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02315144

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

8.7

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: TV48108 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TV48108 - Healthy Volunteers 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	Drug: TV48108 TV48108 15, 60, 120 μg Other Names: 48108
Placebo Comparator: Placebo - Healthy Volunteers Placebo	Drug: Placebo Placebo Comparator Other Names: Matching placebo
Experimental: TV48108 15 µg COPD 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.	Drug: TV48108 TV48108 15, 60, 120 μg Other Names: 48108
Experimental: TV48108 60 µg COPD Stage 2	Drug: TV48108 TV48108 15, 60, 120 μg Other Names: 48108
Experimental: TV48108 120 µg COPD Stage 2 .	Drug: TV48108 TV48108 15, 60, 120 μg Other Names: 48108

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Teva Investigational Site 13038	Medford	Oregon	United States
2	Teva Investigational Site 13039	Spartanburg	South Carolina	United States
3	Teva Investigational Site 78992	Clayton		Australia
4	Teva Investigational Site 78993	Daws Park		Australia
5	Teva Investigational Site 78991	Melbourne		Australia
6	Teva Investigational Site 79041	Auckland		New Zealand
7	Teva Investigational Site 79040	Christchurch		New Zealand

Sponsors and Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Teva Branded Pharmaceutical Products R&D, Inc.

ClinicalTrials.gov Identifier:

NCT02315144

Other Study ID Numbers:

TV48108-COPD-10045

First Posted:

Dec 11, 2014

Last Update Posted:

Nov 9, 2021

Last Verified:

Nov 1, 2021

Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.

COPD

bronchodilation

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 9, 2021