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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014