Clinical Trials/NCT02315144

NCT02315144

Terminated

Phase 1

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

Teva Branded Pharmaceutical Products R&D, Inc.7 sites in 3 countries61 target enrollmentApril 2015

ConditionsChronic Obstructive Pulmonary Disease

InterventionsTV48108 Placebo

DrugsTV48108 Placebo

Overview

Phase: Phase 1
Intervention: TV48108
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Enrollment: 61
Locations: 7
Primary Endpoint: Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

August 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Responsible Party

Sponsor

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\^
•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

Arms & Interventions

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

Intervention: TV48108

Placebo - Healthy Volunteers

Placebo

Intervention: Placebo

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.

Intervention: TV48108

TV48108 60 µg COPD

Stage 2

Intervention: TV48108

TV48108 120 µg COPD

Stage 2 .

Intervention: TV48108

Outcomes

Primary Outcomes

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 Outcomes

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)