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Completed

NCT Number: NCT01035515

BIIB014 Cardiovascular Monitoring Study

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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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quintiles Inc

Overland Park, Kansas, 66211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

Single dose oral capsule placebo comparator

BIIB014 50mg

Drug

Single dose oral capsule 50mg BIIB014

BIIB014 100mg

Drug

Single dose oral capsule 100mg BIIB014

Primary outcomes

  1. Supine Blood pressure

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 18, 2009
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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