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

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

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

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Placebo; Drug: TV48108

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Percentage of Participants with Adverse Events	28 Days
Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)	Day 1 (pre-dose, up to 12 hours post-dose)

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 6, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: COPD; bronchodilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TV48108-COPD-10045