Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

TV48108

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, bronchodilation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Teva Investigational Site 13038
Teva Investigational Site 13039
Teva Investigational Site 78992
Teva Investigational Site 78993
Teva Investigational Site 78991
Teva Investigational Site 79041
Teva Investigational Site 79040

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

TV48108 - Healthy Volunteers

Placebo - Healthy Volunteers

TV48108 15 µg COPD

TV48108 60 µg COPD

TV48108 120 µg COPD

Arm Description

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

Placebo

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.

Stage 2

Stage 2 .

Outcomes

Primary Outcome Measures

Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).

Secondary Outcome Measures

Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)

Percentage of Participants with Adverse Events

Full Information

NCT ID

NCT02315144

First Posted

December 9, 2014

Last Updated

November 6, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02315144

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

Business decision

Study Start Date

April 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, bronchodilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TV48108 - Healthy Volunteers

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo - Healthy Volunteers

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

TV48108 15 µg COPD

Arm Type

Experimental

Arm Description

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.

Arm Title

TV48108 60 µg COPD

Arm Type

Experimental

Arm Description

Stage 2

Arm Title

TV48108 120 µg COPD

Arm Type

Experimental

Arm Description

Stage 2 .

Intervention Type

Drug

Intervention Name(s)

TV48108

Other Intervention Name(s)

48108

Intervention Description

TV48108 15, 60, 120 μg

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Matching placebo

Intervention Description

Placebo Comparator

Primary Outcome Measure Information:

Title

Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).

Time Frame

Day 1 (pre-dose, up to 12 hours post-dose)

Secondary Outcome Measure Information:

Title

Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)

Time Frame

Day 1 (pre-dose, up to 12 hours post-dose)

Title

Percentage of Participants with Adverse Events

Time Frame

28 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 13038

City

Medford

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 13039

City

Spartanburg

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 78992

City

Clayton

Country

Australia

Facility Name

Teva Investigational Site 78993

City

Daws Park

Country

Australia

Facility Name

Teva Investigational Site 78991

City

Melbourne

Country

Australia

Facility Name

Teva Investigational Site 79041

City

Auckland

Country

New Zealand

Facility Name

Teva Investigational Site 79040

City

Christchurch

Country

New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs