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BIIB014 Cardiovascular Monitoring Study

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01035515
First received: December 17, 2009
Last updated: June 17, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Placebo
Drug: BIIB014 50mg
Drug: BIIB014 100mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Single-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Cardiovascular Effects of Single Doses of Oral BIIB014 in Healthy Volunteers

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Supine Blood pressure [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: December 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035515

Locations
United States, Kansas
Quintiles Inc
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Study MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT01035515     History of Changes
Other Study ID Numbers: 204HV102
Study First Received: December 17, 2009
Last Updated: June 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Healthy subjects

ClinicalTrials.gov processed this record on May 21, 2013