MedDataX Logo

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

NCT ID: NCT00760565

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease (PAD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

RO4905417

Intervention Type DRUG

3mg/kg iv every 28 days for 3 infusions

10

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

20mg/kg iv every 28 days for 3 infusions

11

Group Type EXPERIMENTAL

RO4905417

Intervention Type DRUG

20mg/kg iv every 28 days for 3 infusions

12

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

20mg/kg iv every 28 days for 3 infusions

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

3mg/kg iv every 28 days for 3 infusions

3

Group Type EXPERIMENTAL

RO4905417

Intervention Type DRUG

3mg/kg iv every 28 days for 3 infusions

4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

3mg/kg iv every 28 days for 3 infusions

5

Group Type EXPERIMENTAL

RO4905417

Intervention Type DRUG

7mg/kg iv every 28 days for 3 infusions

6

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

7mg/kg iv every 28 days for 3 infusions

7

Group Type EXPERIMENTAL

RO4905417

Intervention Type DRUG

7mg/kg iv every 28 days for 3 infusions

8

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

7mg/kg iv every 28 days for 3 infusions

9

Group Type EXPERIMENTAL

RO4905417

Intervention Type DRUG

20mg/kg iv every 28 days for 3 infusions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RO4905417

3mg/kg iv every 28 days for 3 infusions

Intervention Type DRUG

RO4905417

20mg/kg iv every 28 days for 3 infusions

Intervention Type DRUG

RO4905417

7mg/kg iv every 28 days for 3 infusions

Intervention Type DRUG

placebo

3mg/kg iv every 28 days for 3 infusions

Intervention Type DRUG

placebo

7mg/kg iv every 28 days for 3 infusions

Intervention Type DRUG

placebo

20mg/kg iv every 28 days for 3 infusions

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gainesville, Florida, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Cincinnati, Ohio, United States

Site Status

San Antonio, Texas, United States

Site Status

Heidelberg, , Australia

Site Status

Gatineau, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland United States Australia Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BP21617

Identifier Type: -

Identifier Source: org_study_id