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

NCT02315144 | Terminated Phase 1

• 1 other identifier: TV48108-COPD-10045
• Study Type: interventional
• Target: 61
• Locations: 3 countries
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (5)

TV48108 - Healthy Volunteers

EXPERIMENTAL

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

Placebo - Healthy Volunteers

PLACEBO COMPARATOR

Placebo

Drug: Placebo

TV48108 15 µg COPD

EXPERIMENTAL

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 60 µg COPD

EXPERIMENTAL

Stage 2

Drug: TV48108

TV48108 120 µg COPD

EXPERIMENTAL

Stage 2 .

Drug: TV48108

Interventions

TV48108 DRUG

TV48108 15, 60, 120 μg

Also known as: 48108

TV48108 - Healthy Volunteers; TV48108 120 µg COPD; TV48108 15 µg COPD; TV48108 60 µg COPD

Placebo DRUG

Placebo Comparator

Also known as: Matching placebo

Placebo - Healthy Volunteers

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Other criteria apply, please contact the investigator for more information

Sponsors & Collaborators

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

Study Sites (7)

Teva Investigational Site 13038

Medford, Oregon, United States

Location

Teva Investigational Site 13039

Spartanburg, South Carolina, United States

Location

Teva Investigational Site 78992

Clayton, Australia

Location

Teva Investigational Site 78993

Daws Park, Australia

Location

Teva Investigational Site 78991

Melbourne, Australia

Location

Teva Investigational Site 79041

Auckland, New Zealand

Location

Teva Investigational Site 79040

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

US (2); AU (3); NZ (2)