Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

NCT01063101 | Completed Phase 1

• 1 other identifier: 950901
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA).

  7 months (= anticipated study duration)

Study Arms (2)

BAX 513

EXPERIMENTAL

Capsule - one of 5 dose levels (per randomization) - BID (= twice a day)

Other: Fucoidan (extract of Laminaria japonica)

Capsule (cellulose)

PLACEBO COMPARATOR

Capsule - one of 5 dose levels (per randomization) - BID

Other: Placebo

Interventions

Fucoidan (extract of Laminaria japonica) OTHER

Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID

Also known as: BAX 513

BAX 513

Placebo OTHER

Cellulose filled capsule - oral administration - 5 different dose levels - BID

Capsule (cellulose)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxalta now part of Shire: lead

Study Sites (1)

University Clinic for Clinical Pharmacology, General Hospital Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

fucoidan

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: January 29, 2010
• Primary Completion: July 22, 2010
• Study Completion: August 1, 2010
• Last Updated: May 5, 2021

Record last verified: 2021-05

Locations

AU (1)