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Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063101
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : January 25, 2018
Information provided by:

Tracking Information
First Submitted Date  ICMJE February 4, 2010
First Posted Date  ICMJE February 5, 2010
Last Update Posted Date January 25, 2018
Actual Study Start Date  ICMJE January 29, 2010
Actual Primary Completion Date July 22, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA). [ Time Frame: 7 months (= anticipated study duration) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase 1 Dosing Study of BAX 513 in Healthy Volunteers
Official Title  ICMJE A Phase 1 Study to Evaluate the Effects of BAX 513 on Hemostatic Parameters in Healthy Volunteers
Brief Summary The purpose of the study is to investigate whether orally administered BAX 513 (different doses administered for 5 days) affects hemostatic parameters in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Other: Fucoidan (extract of Laminaria japonica)
    Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID
    Other Name: BAX 513
  • Other: Placebo
    Cellulose filled capsule - oral administration - 5 different dose levels - BID
Study Arms  ICMJE
  • Experimental: BAX 513
    Capsule - one of 5 dose levels (per randomization) - BID (= twice a day)
    Intervention: Other: Fucoidan (extract of Laminaria japonica)
  • Placebo Comparator: Capsule (cellulose)
    Capsule - one of 5 dose levels (per randomization) - BID
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2010)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2010
Actual Primary Completion Date July 22, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is >= 18 and < 70 years old at the time of screening
  • Is able to provide signed and dated informed consent
  • Is a healthy male or female adult
  • If female and of childbearing potential, subject demonstrates a negative serum pregnancy test, and agrees to employ adequate birth control measures; (e.g., oral contraceptives, barrier method) for the duration of the study
  • If female and receiving hormone replacement therapy (HRT), subject agrees to abstain from HRT for the duration of the study
  • Subject's medical history and physical exam are normal
  • Subject's lab values for complete blood count (CBC) and clinical chemistry are within normal ranges
  • Is able to comprehend and comply with all aspects of the protocol and signed informed consent

Exclusion Criteria:

  • If female, subject is pregnant or lactating at the time of study enrollment
  • Has participated in another clinical study involving an investigational product (IP) or device within 30 days of screening or is scheduled to participate in another clinical study involving an IP or device during the course of this study
  • Has a history of drug allergy in general or hypersensitivity to fucoidan containing products/foods or seafoods
  • Medical and/or family history of thrombophilic tendencies, eg Protein C or S-deficiency, ATIII deficiency, FV Leiden mutation, Prothrombin 20210A mutation, lupus type inhibitor, antiphospholipid antibodies
  • Medical history or clinical findings of a significant bleeding disorder
  • Medical history of thrombotic events such as venous thromboembolism (VTE), myocardial infarction (MI), stroke or transient ischemic attack (TIA)
  • Any other clinically relevant history of disease, eg malabsorption disorders, malignancies
  • Any clinically significant abnormal laboratory values or abnormal ECG findings that in the opinion of the investigator are considered clinically relevant
  • Seropositivity for HBs-Ag, HCV, HIV-1 or HIV-2 antibodies
  • Symptoms of a clinically relevant illness within 3 weeks before screening
  • A history of, or suspected, drug or alcohol abuse, or subject tests positive on a Drugs of Abuse screen within 1 week of dosing
  • Intake of IP or related (fucoidan-containing) product within 1 week prior to study enrollment
  • Any planned surgical or dental procedure during the course of this study
  • Any recent surgery within 30 days of enrollment
  • Presence of signs or symptoms consistent with an infection, such as fever, chills, or nausea during screening in this study
  • Chronic or regular use of aspirin, ibuprofen, coumarin derivatives, antiplatelet drugs, within 1 week before enrollment
  • Use of concomitant drugs diclofenac or [paracetamol if > 2 g/day] within 1 week before first day of study dosing
  • Plasmapheresis or platelet donation within 3 weeks of screening and until final visit
  • Any medical condition that may compromise the ability to give written informed consent or to comply with the study protocol
  • Subject is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01063101
Other Study ID Numbers  ICMJE 950901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wing-Yen Wong, MD; Medical Director, Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxalta now part of Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wing-Yen Wong, MD Baxter Healthcare Corporation
PRS Account Shire
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP