Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

May 3, 2021 updated by: Baxalta now part of Shire

A Phase 1 Study to Evaluate the Effects of BAX 513 on Hemostatic Parameters in Healthy Volunteers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • University Clinic for Clinical Pharmacology, General Hospital Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA).
Time Frame: 7 months (= anticipated study duration)
7 months (= anticipated study duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxalta now part of Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 950901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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