Healthy VolunteersPhase 1NCT01063101
Phase 1 Dosing Study of BAX 513 in Healthy Volunteers
A Phase 1 study testing Fucoidan (extract of Laminaria japonica) in people with Healthy Volunteers, run by Baxalta now part of Shire at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Fucoidan (extract of Laminaria japonica)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jan 2010to 1 Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Clinic for Clinical Pharmacology, General Hospital Vienna
Vienna, 1090
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- Fucoidan (extract of Laminaria japonica), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fucoidan (extract of Laminaria japonica)Other
Also called BAX 513
Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID
PlaceboOther
Cellulose filled capsule - oral administration - 5 different dose levels - BID
| Study group | Role | What they receive |
|---|---|---|
| BAX 513 | Experimental | Capsule - one of 5 dose levels (per randomization) - BID (= twice a day) Receives: Other: Fucoidan (extract of Laminaria japonica) |
| Capsule (cellulose) | Placebo comparator | Capsule - one of 5 dose levels (per randomization) - BID Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA).
Measured: 7 months (= anticipated study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study start29 Jan 2010
- Primary completion22 Jul 2010
- Study completion1 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063101
- Sponsor's protocol ID
- 950901
- Status last verified
- May 2021
- First submitted
- 4 Feb 2010
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effects of BAX 513 on Hemostatic Parameters in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01063101
- Acronym / sponsor ID
- 950901
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2010 (actual)
- Primary completion
- 22 Jul 2010 (actual)
- Study completion
- 1 Aug 2010 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAX 513 | Experimental | Other: Fucoidan (extract of Laminaria japonica)Capsule - one of 5 dose levels (per randomization) - BID (= twice a day) |
| Capsule (cellulose) | Placebo comparator | Other: PlaceboCapsule - one of 5 dose levels (per randomization) - BID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fucoidan (extract of Laminaria japonica)Also: BAX 513Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID | Other | BAX 513 |
| PlaceboCellulose filled capsule - oral administration - 5 different dose levels - BID | Other | Capsule (cellulose) |
Primary outcome
Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA).
Time frame: 7 months (= anticipated study duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fucoidan (extract of Laminaria japonica) in people with Healthy Volunteers, run by Baxalta now part of Shire at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA). (time frame: 7 months (= anticipated study duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.