A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | September 2008 |
| End Date: | June 2011 |
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
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.
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.
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.
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