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

NCT ID: NCT02315144

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-08-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; bronchodilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

TV48108

Intervention Type: DRUG

TV48108 15, 60, 120 μg

Placebo - Healthy Volunteers

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Comparator

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.

Group Type: EXPERIMENTAL

TV48108

Intervention Type: DRUG

TV48108 15, 60, 120 μg

TV48108 60 µg COPD

Stage 2

Group Type: EXPERIMENTAL

TV48108

Intervention Type: DRUG

TV48108 15, 60, 120 μg

TV48108 120 µg COPD

Stage 2 .

Group Type: EXPERIMENTAL

TV48108

Intervention Type: DRUG

TV48108 15, 60, 120 μg

Interventions

TV48108

TV48108 15, 60, 120 μg

Intervention Type: DRUG

Placebo

Placebo Comparator

Intervention Type: DRUG

Other Intervention Names

48108; Matching placebo

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 13038

Medford, Oregon, United States

Teva Investigational Site 13039

Spartanburg, South Carolina, United States

Teva Investigational Site 78992

Clayton, , Australia

Teva Investigational Site 78993

Daws Park, , Australia

Teva Investigational Site 78991

Melbourne, , Australia

Teva Investigational Site 79041

Auckland, , New Zealand

Teva Investigational Site 79040

Christchurch, , New Zealand

Countries

United States; Australia; New Zealand

Other Identifiers

TV48108-COPD-10045

Identifier Type: -

Identifier Source: org_study_id