BIIB014 Cardiovascular Monitoring Study

June 17, 2010 updated by: Biogen

A Single-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Cardiovascular Effects of Single Doses of Oral BIIB014 in Healthy Volunteers

The study will examine the effects of a single dose of BIIB014 on blood pressure and haemodynamic variables in healthy volunteers over 24 hours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Quintiles Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female subjects
  • Between the ages of 18 and 50, inclusive.
  • Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

  • Clinically significant abnormalities (as determined by the Investigator)
  • Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm One
Arm 1 of 6 cross-over arms
Drug: Placebo
Single dose oral capsule placebo comparator
Drug: BIIB014 50mg
Single dose oral capsule 50mg BIIB014
Drug: BIIB014 100mg
Single dose oral capsule 100mg BIIB014
EXPERIMENTAL: Arm Two
Arm 2 of 6 cross-over arms
Drug: Placebo
Single dose oral capsule placebo comparator
Drug: BIIB014 50mg
Single dose oral capsule 50mg BIIB014
Drug: BIIB014 100mg
Single dose oral capsule 100mg BIIB014
EXPERIMENTAL: Arm Three
Arm 3 of 6 cross-over arms
Drug: Placebo
Single dose oral capsule placebo comparator
Drug: BIIB014 50mg
Single dose oral capsule 50mg BIIB014
Drug: BIIB014 100mg
Single dose oral capsule 100mg BIIB014
EXPERIMENTAL: Arm Four
Arm 4 of 6 cross-over arms
Drug: Placebo
Single dose oral capsule placebo comparator
Drug: BIIB014 50mg
Single dose oral capsule 50mg BIIB014
Drug: BIIB014 100mg
Single dose oral capsule 100mg BIIB014
EXPERIMENTAL: Arm Five
Arm 5 of 6 cross-over arms
Drug: Placebo
Single dose oral capsule placebo comparator
Drug: BIIB014 50mg
Single dose oral capsule 50mg BIIB014
Drug: BIIB014 100mg
Single dose oral capsule 100mg BIIB014
EXPERIMENTAL: Arm Six
Arm 1 of 6 cross-over arms
Drug: Placebo
Single dose oral capsule placebo comparator
Drug: BIIB014 50mg
Single dose oral capsule 50mg BIIB014
Drug: BIIB014 100mg
Single dose oral capsule 100mg BIIB014

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Supine Blood pressure
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (ESTIMATE)

December 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 17, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 204HV102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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