- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02206100
PK and PD of Single, Escalating Doses of PER977 Following Enoxaparin (PER977)
May 19, 2020 updated by: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Phase I/II Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Single, Hourly-Repeating, Escalating Doses of PER977 Following a Single Subcutaneous Dose of Enoxaparin
PER977 administration following a single dose of enoxaparin
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Single escalating doses of PER977 from 100 to 300 mg, of 25 mg PER977 x 4 doses will be administered following administration of enoxaparin.
Serial pharmacokinetic and pharmacodynamic assessments ( whole blood clotting time) will be performed.
Adverse events will be monitored.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- 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
-
-
Kansas
-
Overland Park, Kansas, United States, 66211
- Quintiles
-
-
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
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
- Adults age 18 to 65 years, inclusive
- Laboratory values have no clinically significant abnormalities
- No clinically significant findings on 12-lead electrocardiogram
- Body mass index (BMI) 18 to ≤ 27 kg/m2, inclusive
- Male subjects agree to use appropriate contraception
- 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.
- 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:
- History or current evidence of clinically significant disease. Current evidence of liver function tests or renal function tests 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).
- History of unexplained syncope
- Hypersensitivity to enoxaparin sodium, thrombocytopenia with a positive in vitro test to anti-platelet antibody in the presence of enoxaparin sodium, hypersensitivity to heparin or porcine products or any other contraindication to enoxaparin
- History of major bleeding, trauma, surgical procedure of any type, or vaginal delivery within six months prior to screening
- History of peptic ulcer, gastrointestinal bleeding or bleeding from hemorrhoids within six months prior to screening
- History of minor bleeding episodes such as epistaxis, or gingival bleeding within 1 month prior to screening
- 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
- Females with a history of dysfunctional uterine bleeding who have not undergone hysterectomy, including history of menorrhagia, metrorrhagia or polymenorrhea
- Pregnant or breast-feeding
- Males with a history of hormone therapy within 3 months prior to screening
- 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.
- Taking any type of medication for more than 14 consecutive days within the 4 weeks prior to study entry
- Positive serologic test for HIV, hepatitis C antibody, or hepatitis B surface antigen
- Donation of blood or blood products within 56 days prior to screening
- History of randomization in any prior study of PER977
- Randomization in any study with an investigational compound or device within 30 days prior to signing informed consent
- 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
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
100 mg PER977 (10 subjects); the dose may be repeated two (2) times after an approximate one (1) hour interval for a maximum total of three (3) doses
|
Reversal of edoxaban-induced anticoagulation
reversal of edoxaban-induced anticoagulation
|
Experimental: Cohort 2
200 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour for a maximum total of two (2) doses
|
Reversal of edoxaban-induced anticoagulation
reversal of edoxaban-induced anticoagulation
|
Experimental: Cohort 3
300 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour after the initial dose for a maximum of total of two (2) doses
|
Reversal of edoxaban-induced anticoagulation
reversal of edoxaban-induced anticoagulation
|
Experimental: Cohort 4
4 x 25 mg PER977 (10 subjects); study drug will be administered every 30 minutes for a total of 4 doses (cumulative dose of 100 mg PER977)
|
Reversal of edoxaban-induced anticoagulation
reversal of edoxaban-induced anticoagulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of adverse events
Time Frame: 1 day
|
Assessment of the number of subjects who experience adverse events and the number and type of adverse events
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reversal of enoxaparin anticoagulation
Time Frame: 1 day
|
Measurement of the degree of change in whole blood clotting time and the proportion of subjects who achieve complete or partial reversal of anticoagulation
|
1 day
|
Pharmacokinetics of enoxaparin
Time Frame: 1 day
|
Measurement of the pharmacokinetic characteristics of enoxaparin
|
1 day
|
Pharmacokinetics of PER977 and its metabolite
Time Frame: 2 days
|
Measurement of the pharmacokinetic characteristics of PER977 and its metabolite
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
April 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
June 2, 2014
First Submitted That Met QC Criteria
July 30, 2014
First Posted (Estimate)
August 1, 2014
Study Record Updates
Last Update Posted (Actual)
May 21, 2020
Last Update Submitted That Met QC Criteria
May 19, 2020
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PER977-01-003
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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