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Completed

NCT Number: NCT00760565

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

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.

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Key information

Conditions

Peripheral Arterial Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Heidelberg, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RO4905417

Drug

3mg/kg iv every 28 days for 3 infusions

Placebo

Drug

3mg/kg iv every 28 days for 3 infusions

Primary outcomes

  1. Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.

    Time frame: Throughout study

Secondary outcomes

  1. Pharmacodynamics: bleeding time; protein/vascular markers

    Time frame: Throughout study

  2. Pharmacokinetics of RO4905417

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 26, 2008
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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