HealthyPhase 1/2PER977NCT02206100
PK and PD of Single, Escalating Doses of PER977 Following Enoxaparin
A Phase 1/2 study testing PER977 and enoxaparin in people with Healthy, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
PER977 administration following a single dose of enoxaparin Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PER977 and enoxaparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2014
- Phase
- Phase 1/2
- 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
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy
- Being tested
- PER977, Placebo, enoxaparin
- Keywords
- PER977, enoxaparin, anticoagulation reversal, whole blood clotting time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PER977Drug
reversal of edoxaban-induced anticoagulation
PlaceboDrug
Reversal of edoxaban-induced anticoagulation
enoxaparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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 Receives: Drug: PER977; Drug: Placebo; Drug: enoxaparin |
| Cohort 2 | Experimental | 200 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour for a maximum total of two (2) doses Receives: Drug: PER977; Drug: Placebo; Drug: enoxaparin |
| Cohort 3 | Experimental | 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 Receives: Drug: PER977; Drug: Placebo; Drug: enoxaparin |
| Cohort 4 | Experimental | 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) Receives: Drug: PER977; Drug: Placebo; Drug: enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Assessment of the number of subjects who experience adverse events and the number and type of adverse events
Measured: 1 day
Secondary outcomes (3)
Reversal of enoxaparin anticoagulation
Measurement of the degree of change in whole blood clotting time and the proportion of subjects who achieve complete or partial reversal of anticoagulation
Measured: 1 day
Pharmacokinetics of enoxaparin
Measurement of the pharmacokinetic characteristics of enoxaparin
Measured: 1 day
Pharmacokinetics of PER977 and its metabolite
Measurement of the pharmacokinetic characteristics of PER977 and its metabolite
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Rasmussen, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206100
- Sponsor's protocol ID
- PER977-01-003
- Acronym
- PER977
- Status last verified
- Nov 2017
- First submitted
- 2 Jun 2014
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02206100
- Acronym / sponsor ID
- PER977 / PER977-01-003
- Conditions
- Healthy
- Keywords
- PER977, enoxaparin, anticoagulation reversal, whole blood clotting time
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Aug 2014 (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.
PER977 administration following a single dose of enoxaparin
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PER977, Drug: Placebo, Drug: enoxaparin100 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 |
| Cohort 2 | Experimental | Drug: PER977, Drug: Placebo, Drug: enoxaparin200 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour for a maximum total of two (2) doses |
| Cohort 3 | Experimental | Drug: PER977, Drug: Placebo, Drug: enoxaparin300 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 |
| Cohort 4 | Experimental | Drug: PER977, Drug: Placebo, Drug: enoxaparin4 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| PER977reversal of edoxaban-induced anticoagulation | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboReversal of edoxaban-induced anticoagulation | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| enoxaparin | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
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
3 secondary outcomes
Reversal of enoxaparin anticoagulation
Time frame: 1 day
Pharmacokinetics of enoxaparin
Time frame: 1 day
Pharmacokinetics of PER977 and its metabolite
Time frame: 2 days
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 21 May 2020.
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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.
Scott Rasmussen, MD principal investigator
Quintiles, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PER977 and enoxaparin in people with Healthy, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, 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 7 inclusion and 17 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 21 May 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of adverse events (time frame: 1 day). 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 21 May 2020.