Back to resultsA Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
Primary Purpose
Peripheral Arterial Disease (PAD)
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO4905417
RO4905417
RO4905417
placebo
placebo
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease (PAD)
Eligibility Criteria
Inclusion Criteria:
- healthy males and females aged 18-65 years (Arms 1,2,5,6,9,10);
- BMI 18-30kg/m2 (Arms 1,2,5,6,9,10);
- males and females aged 45-75 years with confirmed stable PAD (Arms 3,4,7,8,11,12);
- on a stable dose of statin, aspirin or clopidogrel for at least one month prior to the study (Arms 3,4,7,8,11,12);
- BMI 17.5-35kg/m2 (Arms 3,4,7,8,11,12).
Exclusion Criteria:
- patients with pain at rest and/or local complications;
- history of any cardiovascular event within the previous 6 months;
- treatment with drugs potentially affecting coagulation time or platelet aggregation (except aspirin or clopidogrel);
- evidence of hepatic or renal impairment;
- history of bleeding disorders.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
1
10
11
12
2
3
4
5
6
7
8
9
Arm Description
Outcomes
Primary Outcome Measures
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.
Secondary Outcome Measures
Pharmacodynamics: bleeding time; protein/vascular markers
Pharmacokinetics of RO4905417
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00760565
Brief Title
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
Official Title
A Randomized, Double-Blind, Multiple-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4905417 Following Intravenous Infusion in Healthy Volunteers and Patients With Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single center, multiple ascending dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers and patients with peripheral arterial disease. Three groups of 10 healthy volunteers will receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either 3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or placebo iv every 28 days for a total of three infusions. The study will have an adaptive design with ongoing assessment of safety and tolerability prior to initiation of the next dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease (PAD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
10
Arm Type
Placebo Comparator
Arm Title
11
Arm Type
Experimental
Arm Title
12
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Placebo Comparator
Arm Title
7
Arm Type
Experimental
Arm Title
8
Arm Type
Placebo Comparator
Arm Title
9
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO4905417
Intervention Description
3mg/kg iv every 28 days for 3 infusions
Intervention Type
Drug
Intervention Name(s)
RO4905417
Intervention Description
20mg/kg iv every 28 days for 3 infusions
Intervention Type
Drug
Intervention Name(s)
RO4905417
Intervention Description
7mg/kg iv every 28 days for 3 infusions
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
3mg/kg iv every 28 days for 3 infusions
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
7mg/kg iv every 28 days for 3 infusions
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
20mg/kg iv every 28 days for 3 infusions
Primary Outcome Measure Information:
Title
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Pharmacodynamics: bleeding time; protein/vascular markers
Time Frame
Throughout study
Title
Pharmacokinetics of RO4905417
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
healthy males and females aged 18-65 years (Arms 1,2,5,6,9,10);
BMI 18-30kg/m2 (Arms 1,2,5,6,9,10);
males and females aged 45-75 years with confirmed stable PAD (Arms 3,4,7,8,11,12);
on a stable dose of statin, aspirin or clopidogrel for at least one month prior to the study (Arms 3,4,7,8,11,12);
BMI 17.5-35kg/m2 (Arms 3,4,7,8,11,12).
Exclusion Criteria:
patients with pain at rest and/or local complications;
history of any cardiovascular event within the previous 6 months;
treatment with drugs potentially affecting coagulation time or platelet aggregation (except aspirin or clopidogrel);
evidence of hepatic or renal impairment;
history of bleeding disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 6S9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
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