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

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Ipratropium

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