BIIB014 Cardiovascular Monitoring Study

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: BIIB014 50mg
* Drug: BIIB014 100mg


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supine Blood pressure |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subjects