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BIIB014 Cardiovascular Monitoring Study

NCT ID: NCT01035515

Last Updated: 2010-06-22

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm One

Arm 1 of 6 cross-over arms

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose oral capsule placebo comparator

BIIB014 50mg

Intervention Type DRUG

Single dose oral capsule 50mg BIIB014

BIIB014 100mg

Intervention Type DRUG

Single dose oral capsule 100mg BIIB014

Arm Two

Arm 2 of 6 cross-over arms

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose oral capsule placebo comparator

BIIB014 50mg

Intervention Type DRUG

Single dose oral capsule 50mg BIIB014

BIIB014 100mg

Intervention Type DRUG

Single dose oral capsule 100mg BIIB014

Arm Three

Arm 3 of 6 cross-over arms

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose oral capsule placebo comparator

BIIB014 50mg

Intervention Type DRUG

Single dose oral capsule 50mg BIIB014

BIIB014 100mg

Intervention Type DRUG

Single dose oral capsule 100mg BIIB014

Arm Four

Arm 4 of 6 cross-over arms

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose oral capsule placebo comparator

BIIB014 50mg

Intervention Type DRUG

Single dose oral capsule 50mg BIIB014

BIIB014 100mg

Intervention Type DRUG

Single dose oral capsule 100mg BIIB014

Arm Five

Arm 5 of 6 cross-over arms

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose oral capsule placebo comparator

BIIB014 50mg

Intervention Type DRUG

Single dose oral capsule 50mg BIIB014

BIIB014 100mg

Intervention Type DRUG

Single dose oral capsule 100mg BIIB014

Arm Six

Arm 1 of 6 cross-over arms

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose oral capsule placebo comparator

BIIB014 50mg

Intervention Type DRUG

Single dose oral capsule 50mg BIIB014

BIIB014 100mg

Intervention Type DRUG

Single dose oral capsule 100mg BIIB014

Interventions

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Placebo

Single dose oral capsule placebo comparator

Intervention Type DRUG

BIIB014 50mg

Single dose oral capsule 50mg BIIB014

Intervention Type DRUG

BIIB014 100mg

Single dose oral capsule 100mg BIIB014

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Biogen Idec

Locations

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Quintiles Inc

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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204HV102

Identifier Type: -

Identifier Source: org_study_id

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