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OpenTrials
Completed

NCT Number: NCT01453426

Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers

This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Melbourne, Victoria, Australia

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About this study

The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.

The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must give written informed consent and any authorizations required by local law
  • All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion criteria

  • History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
  • History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
  • History of severe allergic or anaphylactic reactions
  • Known history of or positive test result for Human Immunodeficiency Virus (HIV)
  • Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
  • Female subjects who are pregnant or currently breastfeeding

Treatment and study plan

BG00012 Dose 1

Drug

BG00012 Dose 2

Drug

Primary outcomes

  1. AUC of BG00012

    Time frame: First dose to 24 hours

  2. Cmax of BG00012

    Time frame: First dose to 24 hours

Secondary outcomes

  1. Number of Adverse Events, as a measure of safety and tolerability

    Time frame: Subjects will be followed for the duration of the study, an expected 20 days

  2. Number of Serious Adverse Events, as a measure of safety and tolerability

    Time frame: Subjects will be followed for the duration of the study, an expected 20 days

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

Acronym: 109HV108

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2011
Registry last updated
Sep 16, 2013

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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