Clinical trial NCT02315144: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
bronchodilation
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).
timeFrame: Day 1 (pre-dose, up to 12 hours post-dose)
Secondary outcomes:
measure: Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)
timeFrame: Day 1 (pre-dose, up to 12 hours post-dose)
measure: Percentage of Participants with Adverse Events
timeFrame: 28 Days
Other outcomes:
Locations:
city: Medford
country: United States
facility: Teva Investigational Site 13038
state: Oregon
city: Spartanburg
country: United States
facility: Teva Investigational Site 13039
state: South Carolina
city: Clayton
country: Australia
facility: Teva Investigational Site 78992
city: Daws Park
country: Australia
facility: Teva Investigational Site 78993
city: Melbourne
country: Australia
facility: Teva Investigational Site 78991
city: Auckland
country: New Zealand
facility: Teva Investigational Site 79041
city: Christchurch
country: New Zealand
facility: Teva Investigational Site 79040
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: