A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD). - Full Text View

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Disease (PAD)	Drug: RO4905417 Drug: placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamics: bleeding time; protein/vascular markers [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Pharmacokinetics of RO4905417 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	September 2008
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RO4905417 3mg/kg iv every 28 days for 3 infusions
Placebo Comparator: 2	Drug: placebo 3mg/kg iv every 28 days for 3 infusions
Experimental: 3	Drug: RO4905417 3mg/kg iv every 28 days for 3 infusions
Placebo Comparator: 4	Drug: placebo 3mg/kg iv every 28 days for 3 infusions
Experimental: 5	Drug: RO4905417 7mg/kg iv every 28 days for 3 infusions
Placebo Comparator: 6	Drug: placebo 7mg/kg iv every 28 days for 3 infusions
Experimental: 7	Drug: RO4905417 7mg/kg iv every 28 days for 3 infusions
Placebo Comparator: 8	Drug: placebo 7mg/kg iv every 28 days for 3 infusions
Experimental: 9	Drug: RO4905417 20mg/kg iv every 28 days for 3 infusions
Placebo Comparator: 10	Drug: placebo 20mg/kg iv every 28 days for 3 infusions
Experimental: 11	Drug: RO4905417 20mg/kg iv every 28 days for 3 infusions
Placebo Comparator: 12	Drug: placebo 20mg/kg iv every 28 days for 3 infusions

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760565

Locations

United States, Florida

Gainesville, Florida, United States, 32605
United States, Ohio

Cincinnati, Ohio, United States, 45212

Cincinnati, Ohio, United States, 45219
United States, Texas

San Antonio, Texas, United States, 78229
Australia

Heidelberg, Australia, 3084
Canada, Quebec

Gatineau, Quebec, Canada, J8Y 6S9

Montreal, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00760565 History of Changes
Other Study ID Numbers:	BP21617
Study First Received:	September 25, 2008
Last Updated:	October 14, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis

Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013