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

Peripheral Arterial Disease (PAD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760565
• Other study ID #: BP21617
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2008
• Last updated: November 1, 2016
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

Intervention

Drug:
• RO4905417
3mg/kg iv every 28 days for 3 infusions
• RO4905417
20mg/kg iv every 28 days for 3 infusions
• RO4905417
7mg/kg iv every 28 days for 3 infusions
• placebo
3mg/kg iv every 28 days for 3 infusions
• placebo
7mg/kg iv every 28 days for 3 infusions
• placebo
20mg/kg iv every 28 days for 3 infusions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.		Throughout study	No
Secondary	Pharmacodynamics: bleeding time; protein/vascular markers		Throughout study	No
Secondary	Pharmacokinetics of RO4905417		Throughout study	No