Back to resultsA Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
R7103
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- Male and female patients 40-70 years of age, inclusive.
- Body Mass Index 18-32 kg/m2, inclusive.
- Female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. Male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose.
- Diagnosis of moderate-to-severe COPD (GOLD Stage II-III).
Exclusion Criteria:
- Current smoker or history of smoking in the last three months.
- Use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise.
- History of cardiac conduction abnormalities or ventricular tachyarrhythmias.
- Exacerbation of COPD within 8 weeks before first dosing.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
Arm Description
R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1)
R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2)
R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3)
R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4)
R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5)
R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6)
Outcomes
Primary Outcome Measures
To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01009424
Brief Title
A Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Official Title
A Multi-center, Placebo-controlled, Double Blind Multiple-ascending Dose Study in a Leapfrog Design to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of RO5024118 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1)
Arm Title
2
Arm Type
Experimental
Arm Description
R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2)
Arm Title
3
Arm Type
Experimental
Arm Description
R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3)
Arm Title
4
Arm Type
Experimental
Arm Description
R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4)
Arm Title
5
Arm Type
Experimental
Arm Description
R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5)
Arm Title
6
Arm Type
Experimental
Arm Description
R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6)
Intervention Type
Drug
Intervention Name(s)
R7103
Intervention Description
escalating inhaled dose
Primary Outcome Measure Information:
Title
To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population
Time Frame
18 days per arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients 40-70 years of age, inclusive.
Body Mass Index 18-32 kg/m2, inclusive.
Female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. Male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose.
Diagnosis of moderate-to-severe COPD (GOLD Stage II-III).
Exclusion Criteria:
Current smoker or history of smoking in the last three months.
Use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise.
History of cardiac conduction abnormalities or ventricular tachyarrhythmias.
Exacerbation of COPD within 8 weeks before first dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
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