Study in Healthy Volunteers and COPD Patients to Evaluate the Efficacy and Safety of Inhaled TV46017

NCT02315131 | Terminated Phase 1

• 1 other identifier: TV46017-COPD-10046
• Study Type: interventional
• Target: 53
• 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 TV46017

Conditions

Chronic Obstructive Pulmonary Disease (COPD

Outcome Measures

Primary Outcomes (1)

• FEV1 AUC0-12h

  baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours

  Baseline, 12 hours

Secondary Outcomes (2)

• FEV1

  Baseline, 12 hours

• Percentage of Participants with Adverse Events

  28 Days

Study Arms (6)

TV46017- Healthy Volunteers

EXPERIMENTAL

Stage 1 includes a single-dose treatment period

Drug: TV46017

Placebo - Healthy Volunteers

PLACEBO COMPARATOR

Some healthy subjects will be randomized to receive placebo.

Drug: Placebo

TV46017 15 μg- COPD

EXPERIMENTAL

Stage 2 includes two 24 hour treatment periods with approximately 7 days of washout in between each treatment period; and open label ipratropium bromide pressurized metered-dose inhaler hydrofluoroalkane (HFA) will be administered

Drug: TV46017

TV46017 60 μg- COPD

EXPERIMENTAL

Stage 2

Drug: TV46017

TV46017 120 μg- COPD

EXPERIMENTAL

Stage 2

Drug: TV46017

TV46017 240 μg- COPD

EXPERIMENTAL

Stage 2

Drug: TV46017

Interventions

TV46017 DRUG

TV46017 15, 60, 120, and 240 μg; 4 ascending doses of inhaled TV46017 with an ipratropium bromide reference to evaluate the single administration of 4 ascending doses of inhaled TV46017 in COPD patients.

Also known as: 46017

TV46017 120 μg- COPD; TV46017 15 μg- COPD; TV46017 240 μg- COPD; TV46017 60 μg- COPD; TV46017- Healthy Volunteers

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:

• The subject is a 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/m2. Note: Every effort should be made to enroll approximately equal numbers of men and women in each group.
• The subject is 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
• Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the SV (number of cigarette packs smoked per day multiplied by the number of years smoked; eg, 2 packs/day for 3 years equals a 6 pack year history).
• Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines.
• Male or female; 40 to 75 years of age, inclusive.
• Patient is free of any other medical conditions or concomitant treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
• Other criteria apply, please contact the investigator for more information

You may not qualify if:

• 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
• 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 SV.
• Occurrence of a COPD exacerbation, which is not resolved by 4 weeks or more prior to the SV/informed consent. (Note: An exacerbation of COPD is defined as any worsening of the patient's baseline COPD symptoms requiring any treatment other than rescue albuterol or the patient's regular maintenance therapy. This includes requiring the use of systemic corticosteroids, antibiotics, and/or emergency room visit or hospitalization.)
• 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 13033

St Louis, Missouri, United States

Location

Teva Investigational Site 13034

Raleigh, North Carolina, United States

Location

Teva Investigational Site 78984

Adelaide, Australia

Location

Teva Investigational Site 78985

Nedlands, Australia

Location

Teva Investigational Site 79037

Auckland, New Zealand

Location

Teva Investigational Site 79036

Hamilton, New Zealand

Location

Teva Investigational Site 79034

Wellington, 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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2021-11

Locations

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