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Trial record 87 of 990 for:    Heparin sodium

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin

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ClinicalTrials.gov Identifier: NCT02206087
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Perosphere, Inc.

Brief Summary:
Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of PER977 followed by a one-week washout and then will receive unfractionated heparin followed by a single dose of PER977. The study will provide some insight into the doses that may be required to reverse anticoagulation induced by heparin.

Condition or disease Intervention/treatment Phase
Healthy Drug: PER977 Drug: Placebo Drug: Heparin Sodium Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Phase I/II Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of a Single Escalating Dose of PER977 Following Administration of Unfractionated Heparin
Study Start Date : June 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Cohort 1
100 mg PER977 or placebo administered following heparin sodium
Drug: PER977
Reversal of heparin-induced anticoagulation

Drug: Placebo
Reversal of heparin-induced anticoagulation

Drug: Heparin Sodium
Experimental: Cohort 2
200 mg PER977 or placebo administered following heparin sodium
Drug: PER977
Reversal of heparin-induced anticoagulation

Drug: Placebo
Reversal of heparin-induced anticoagulation

Drug: Heparin Sodium
Experimental: Cohort 3
300 mg PER977 or placebo administered following heparin sodium
Drug: PER977
Reversal of heparin-induced anticoagulation

Drug: Placebo
Reversal of heparin-induced anticoagulation

Drug: Heparin Sodium
Experimental: Cohort 4
400 mg PER977 or placebo administered as a single agent followed by 3-day wash-out. A second dose of 400 mg PER977 or placebo will be administered following heparin sodium injection
Drug: PER977
Reversal of heparin-induced anticoagulation

Drug: Placebo
Reversal of heparin-induced anticoagulation

Drug: Heparin Sodium
Experimental: Cohort 5
500 mg PER977 or placebo will be administered following heparin sodium injection
Drug: PER977
Reversal of heparin-induced anticoagulation

Drug: Placebo
Reversal of heparin-induced anticoagulation

Drug: Heparin Sodium
Experimental: Cohort 6
600 mg PER977 or placebo will be administered following heparin sodium injection
Drug: PER977
Reversal of heparin-induced anticoagulation

Drug: Placebo
Reversal of heparin-induced anticoagulation

Drug: Heparin Sodium



Primary Outcome Measures :
  1. Effect of PER977 on reversal of heparin anticoagulation [ Time Frame: Single day dosing ]
    To identify a dose of PER977 that reverses the effects of heparin as measured by whole blood clotting time


Secondary Outcome Measures :
  1. Safety and tolerability of PER977 administered following heparin [ Time Frame: Single day dosing ]
    Number of participants with adverse events following the administration of PER977



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults age 18 to 65 years, inclusive
  2. Laboratory values have no clinically significant abnormalities as judged by the Investigator.
  3. No clinically significant findings on 12-lead electrocardiogram
  4. Body mass index (BMI) 18 to ≤ 27 kg/m2, inclusive
  5. Male subjects agree to use appropriate contraception .
  6. Female subjects may be surgically sterile or post-menopausal or, if of child-bearing potential, must have a negative serum pregnancy test prior to enrollment, and must agree to use two forms of acceptable contraception for the duration of the study and for a minimum of one complete menstrual cycles or 28 days following discharge from the study.
  7. Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign the informed consent form indicating voluntary consent to participate in the study prior to initiation of screening or study related activities.

Exclusion Criteria:

  1. History or current evidence of clinically significant disease Current evidence of liver function tests or renal function tests (serum creatinine) greater than the upper limit of normal. The presence of Gilbert's Syndrome is acceptable. Current evidence of QTcF >normal (450±10 msec for males or 470±10 msec for females).
  2. History of unexplained syncope
  3. Hypersensitivity to unfractionated heparin, thrombocytopenia with a positive in vitro test to anti-platelet antibody in the presence of unfractionated heparin, hypersensitivity to heparin or porcine products or any other contraindication to unfractionated heparin
  4. History of major bleeding, trauma, surgical procedure of any type, or vaginal delivery within six months prior to screening
  5. History of peptic ulcer, gastrointestinal bleeding or bleeding from hemorrhoids within six months prior to screening
  6. History of minor bleeding episodes such as epistaxis, or gingival bleeding within 1 month prior to screening
  7. Personal or family history of clotting disorder or abnormality, excessive bleeding, thrombovascular disease or any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, or personal history of heparin-induced thrombocytopenia
  8. Females with a history of dysfunctional uterine bleeding who have not undergone hysterectomy, including history of menorrhagia, metrorrhagia or polymenorrhea
  9. Pregnant or breast-feeding
  10. Males with a history of hormone therapy within 3 months prior to screening
  11. Administration of any blood product or anticoagulant within 3 months prior to study entry or any non-steroidal anti-inflammatory drug or cyclooxygenase inhibitor within 2 weeks prior to dosing.
  12. Taking any type of medication for more than 14 consecutive days within the 4 weeks prior to study entry
  13. Positive serologic test for HIV, hepatitis C antibody, or hepatitis B surface antigen
  14. Donation of blood or blood products within 56 days prior to screening
  15. History of randomization in any prior study of PER977
  16. Randomization in any study with an investigational compound or device within 30 days prior to signing informed consent
  17. Active drug or alcohol dependence within the prior 12 months or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206087


Locations
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United States, Kansas
Quintiles
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Perosphere, Inc.
Investigators
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Principal Investigator: Barbara Lomeli, MD Quintiles, Inc.

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Responsible Party: Perosphere, Inc.
ClinicalTrials.gov Identifier: NCT02206087     History of Changes
Other Study ID Numbers: PER977-01-002
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by Perosphere, Inc.:
PER977
heparin
anticoagulation reversal
whole blood clotting time

Additional relevant MeSH terms:
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Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action