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OpenTrials
Completed

NCT Number: NCT01017666

BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam

The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.

Completed

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

InCROM Clinical Research Unit

London, E14NL, United Kingdom

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 45, 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

BIIB014

Drug

BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d

Placebo

Drug

Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d

Primary outcomes

  1. Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo

    Time frame: 24 hours (Cohort 1); 144 hours (Cohort 2)

Secondary outcomes

  1. Adverse Events

    Time frame: Duration of subject participation

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of BIIB014 on the Pharmacokinetics of Rosiglitazone, Warfarin, and Midazolam in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 20, 2009
Registry last updated
Aug 23, 2023

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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