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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Other: Fucoidan (extract of Laminaria japonica); Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Phase 1 Study to Evaluate the Effects of BAX 513 on Hemostatic Parameters in Healthy Volunteers
• Actual Study Start Date: January 29, 2010
• Actual Primary Completion Date: July 22, 2010
• Actual Study Completion Date: August 1, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: BAX 513; Capsule - one of 5 dose levels (per randomization) - BID (= twice a day)	Other: Fucoidan (extract of Laminaria japonica); Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID; Other Name: BAX 513
Placebo Comparator: Capsule (cellulose); Capsule - one of 5 dose levels (per randomization) - BID	Other: Placebo; Cellulose filled capsule - oral administration - 5 different dose levels - BID

Outcome Measures

Primary Outcome Measures :

1. Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA). [ Time Frame: 7 months (= anticipated study duration) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Austria

University Clinic for Clinical Pharmacology, General Hospital Vienna

Vienna, Austria, 1090

Sponsors and Collaborators

Baxalta now part of Shire

Investigators

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

More Information

• Responsible Party: Wing-Yen Wong, MD; Medical Director, Baxter Healthcare Corporation
• ClinicalTrials.gov Identifier: NCT01063101
• Other Study ID Numbers: 950901
• First Posted: February 5, 2010
• Last Update Posted: January 25, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Fucoidan; Anti-Ulcer Agents; Gastrointestinal Agents; Anticoagulants; Antineoplastic Agents