Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT01063101
• Recruitment Status: Completed
• First Posted: February 5, 2010
• Last Update Posted: January 25, 2018
• Sponsor: Baxalta now part of Shire
• Information provided by: Shire

Tracking Information

• First Submitted Date: February 4, 2010
• First Posted Date: February 5, 2010
• Last Update Posted Date: January 25, 2018
• Actual Study Start Date: January 29, 2010
• Actual Primary Completion Date: July 22, 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 1 Dosing Study of BAX 513 in Healthy Volunteers
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy Volunteers

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 4, 2010): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 1, 2010
• Actual Primary Completion Date: July 22, 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT01063101
• Other Study ID Numbers: 950901
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wing-Yen Wong, MD; Medical Director, Baxter Healthcare Corporation
• Study Sponsor: Baxalta now part of Shire
• Collaborators: Not Provided

Investigators

• Study Director: Wing-Yen Wong, MD; Baxter Healthcare Corporation

• PRS Account: Shire
• Verification Date: January 2018