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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02315131




Registration number
NCT02315131
Ethics application status
Date submitted
9/12/2014
Date registered
11/12/2014
Date last updated
31/08/2015

Titles & IDs
Public title
Study in Healthy Volunteers and COPD Patients to Evaluate the Efficacy and Safety of Inhaled TV46017
Scientific 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 TV46017
Secondary ID [1] 0 0
TV46017-COPD-10046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TV46017
Treatment: Drugs - Placebo

Experimental: TV46017- Healthy Volunteers - Stage 1 includes a single-dose treatment period

Placebo Comparator: Placebo - Healthy Volunteers - Some healthy subjects will be randomized to receive placebo.

Experimental: TV46017 15 µg- COPD - 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

Experimental: TV46017 60 µg- COPD - Stage 2

Experimental: TV46017 120 µg- COPD - Stage 2

Experimental: TV46017 240 µg- COPD - Stage 2


Treatment: Drugs: TV46017
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.

Treatment: Drugs: Placebo
Placebo Comparator

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FEV1 AUC0-12h - baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours
Timepoint [1] 0 0
Baseline, 12 hours
Secondary outcome [1] 0 0
FEV1 - baseline adjusted trough 12 hour
Timepoint [1] 0 0
Baseline, 12 hours
Secondary outcome [2] 0 0
Percentage of Participants with Adverse Events
Timepoint [2] 0 0
28 Days

Eligibility
Key inclusion criteria
Stage 1 Inclusion Criteria (healthy volunteers):

- 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

Stage 2 Inclusion Criteria (COPD patients):

- 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

Stage 1
Minimum age
20 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria (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 Exclusion Criteria (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 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.

- Known a1 antitrypsin deficiency, active lung infections (such as tuberculosis or
pneumonia), and lung cancer are absolute exclusionary conditions. A patient who, in
the opinion of the investigator, has any other significant respiratory condition in
addition to COPD should be excluded. Examples may include clinically significant
noncystic bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung
disease. Allergic rhinitis is not exclusionary.

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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 78984 - Adelaide
Recruitment hospital [2] 0 0
Teva Investigational Site 78985 - Nedlands
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hamilton
Country [5] 0 0
New Zealand
State/province [5] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT02315131
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
Teva Pharmaceuticals USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02315131