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Healthy VolunteersPhase 1NCT01513200

Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia

A Phase 1 study testing Unfractionated heparin (UFH), Bendavia and Saline (0.9%, sterile, for infusion) in people with Healthy Volunteers, run by Mighty Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Unfractionated heparin (UFH), Bendavia and Saline (0.9%, sterile, for infusion)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
Jan 2012to Feb 2012
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adult males or females aged between 18 and 65 years of age with signed informed consent.
  • Women who are not post-menopausal (without menstrual bleed for >24 months) or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment with understanding (through informed consent process) to not become pregnant over the duration of the study and must agree to employ an effective form of birth control for the duration of the study [Acceptable forms of birth control are: double-barrier contraceptives (condom, diaphragm with spermicide) or intra-uterine device (IUD) 1 week prior to and at least 30 days post treatment even if hormonal contraceptives are used]

Who cannot join

  • Serum sodium level below the lower limit of the site's clinical laboratory normal range at both study period qualification visits,
  • Platelet value below the lower limit of normal range at screening or admission,
  • aPTT value outside the normal range at screening or admission,
  • Creatinine clearance calculated by the Cockcroft and Gault method calculated to be <90 mL/min for males and <80 mL/min for females,
  • Any addition laboratory abnormalities determined as clinically significant by the Principal Investigator at laboratory screening,
  • Clinically significant abnormalities on physical examination,
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  • Body Mass Index (BMI) of less than 18 kg/m2 or greater than 32 kg/m2,
  • Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,
  • History of seizures or history of epilepsy,
  • History of serious (Principal Investigator judgment) mental illness,
  • Receipt of investigational medicinal product within 30 days before planned date of unfractionated heparin and/or study drug administration,
  • Positive serology for human immunodeficiency virus 1 or 2 (HIV1 or 2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV),
  • Fever greater than 37.5°C at the time of planned dosing,
  • Suspicion of or recent history of alcohol or substance abuse,
  • Donated blood or blood products within the past 30 days,
  • Women who are pregnant or breastfeeding,
  • Employee or family member of the investigational site,
  • Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products or who have used any tobacco products in the 30 days prior to screening,
  • Subjects who are either unwilling to agree to refrain from using or found to be using:
  • Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period
  • Prescription medications from 14 days prior to and 7 days post treatment (excluding hormonal contraceptives)
  • Hormonal contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment
  • Subjects taking aspirin or any other non-steroidal anti-inflammatory agent, either prescription or over-the-counter, within 10 days of treatment,
  • Subjects known to have allergic or untoward effects when using unfractionated heparin,
  • Subjects having previous exposure to Bendavia,
  • Subjects who are expected to undergo any surgical procedure within 14 days of the completion of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014-3616

Other trials in United States

About this study

Official title: A Two Part Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers and the Effects of Bendavia™ and Unfractionated Heparin When Administered Concurrently

This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia.

Being tested
Unfractionated heparin (UFH), Bendavia, Saline (0.9%, sterile, for infusion)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unfractionated heparin (UFH)Drug

    UFH solution for infusion Initially 60U/kg bolus followed by intravenous infusion (12U/kg/hr) for approximately 11 hours

  • BendaviaDrug

    Bendavia for infusion Constant intravenous infusion (Bendavia 0.25mg/kg/hr) for 4 hours

  • Saline (0.9%, sterile, for infusion)Drug

    Saline (placebo) Constant IV infusion for 4 hours

Study groups in NCT01513200
Study groupRoleWhat they receive
UFH + PlaceboPlacebo comparatorUFH (60U/kg bolus followed by 12U/kg/hr for approx.11 hours) with saline (placebo) administered as infusion for the last 4 hours of UFH
Receives: Drug: Unfractionated heparin (UFH); Drug: Saline (0.9%, sterile, for infusion)
UFH + BendaviaExperimentalUFH (60U/kg bolus followed by 12U/kg/hr for approx.11 hours) with Bendavia (0.25mg/kg/hr) administered as infusion for the last 4 hours of UFH
Receives: Drug: Unfractionated heparin (UFH); Drug: Bendavia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean difference over 24 hours in aPTT (activated partial prothrombin time) in seconds when UFH is administered with and without Bendavia

    Difference in group (with/without Bendavia) means of aPPT values will be assessed for statistical significance (Analysis of Variance; ANOVA) at the following time points:

    Pre-UFH, Pre-Study-Drug infusion start and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours Post-Study-Drug infusion start.

    Measured: Pre-UFH to 24 hours post-study drug administration

Secondary outcomes (3)

  1. Mean difference over 12 hours of anti-factor Xa (IU/mL) when UFH is administered with and without Bendavia

    Difference in group (with/without Bendavia) means of aPPT values will be assessed for statistical significance (ANOVA) at the following time points:

    Pre-UFH, Pre-Study-Drug infusion start and 4, 8 and 12 hours Post-Study-Drug infusion start.

    Measured: Pre-UFH to 12 hours post-study drug administration

  2. Mean difference in Bendavia Area Under the Curve(0-infinity) (AUC) when Bendavia is administered with and without UFH (historical data will be used to provide bendavia without UFH)

    Measured: 48 hours post-study-drug administration

  3. Difference in number of adverse events when UFH is administered with and without Bendavia

    Adverse events will be described by treatment group (UFH with and without Bendavia). No statistical analysis of the difference between AEs will be conducted.

    Measured: Pre-dose through Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513200
Sponsor's protocol ID
SPIRI-155
Status last verified
Apr 2012
First submitted
6 Jan 2012
Last updated
19 Apr 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Unfractionated heparin (UFH), Bendavia and Saline (0.9%, sterile, for infusion) in people with Healthy Volunteers, run by Mighty Therapeutics, Inc. at 1 site in United States.

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 2 inclusion and 26 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 19 Apr 2012. 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 United States. 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?

Mean difference over 24 hours in aPTT (activated partial prothrombin time) in seconds when UFH is administered with and without Bendavia (time frame: Pre-UFH to 24 hours post-study drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513200.

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 19 Apr 2012.

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