HealthyPhase 1/2NCT02206087
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin
A Phase 1/2 study testing PER977 and Heparin Sodium 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
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. 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 Heparin Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2016
- 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 as judged by the Investigator.
- 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 (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).
- History of unexplained syncope
- 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
- 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 a Single Escalating Dose of PER977 Following Administration of Unfractionated Heparin
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.
- Conditions
- Healthy
- Being tested
- PER977, Placebo, Heparin Sodium
- Keywords
- PER977, heparin, 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 heparin-induced anticoagulation
PlaceboDrug
Reversal of heparin-induced anticoagulation
Heparin SodiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 100 mg PER977 or placebo administered following heparin sodium Receives: Drug: PER977; Drug: Placebo; Drug: Heparin Sodium |
| Cohort 2 | Experimental | 200 mg PER977 or placebo administered following heparin sodium Receives: Drug: PER977; Drug: Placebo; Drug: Heparin Sodium |
| Cohort 3 | Experimental | 300 mg PER977 or placebo administered following heparin sodium Receives: Drug: PER977; Drug: Placebo; Drug: Heparin Sodium |
| Cohort 4 | Experimental | 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 Receives: Drug: PER977; Drug: Placebo; Drug: Heparin Sodium |
| Cohort 5 | Experimental | 500 mg PER977 or placebo will be administered following heparin sodium injection Receives: Drug: PER977; Drug: Placebo; Drug: Heparin Sodium |
| Cohort 6 | Experimental | 600 mg PER977 or placebo will be administered following heparin sodium injection Receives: Drug: PER977; Drug: Placebo; Drug: Heparin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of PER977 on reversal of heparin anticoagulation
To identify a dose of PER977 that reverses the effects of heparin as measured by whole blood clotting time
Measured: Single day dosing
Secondary outcomes (1)
Safety and tolerability of PER977 administered following heparin
Number of participants with adverse events following the administration of PER977
Measured: Single day dosing
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 startJun 2014
- Primary completionMar 2016
- Study completionMar 2016
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
- 60 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
- Barbara Lomeli, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206087
- Sponsor's protocol ID
- PER977-01-002
- 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 a Single Escalating Dose of PER977 Following Administration of Unfractionated Heparin
- ClinicalTrials.gov ID
- NCT02206087
- Acronym / sponsor ID
- PER977-01-002
- Conditions
- Healthy
- Keywords
- PER977, heparin, anticoagulation reversal, whole blood clotting time
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PER977, Drug: Placebo, Drug: Heparin Sodium100 mg PER977 or placebo administered following heparin sodium |
| Cohort 2 | Experimental | Drug: PER977, Drug: Placebo, Drug: Heparin Sodium200 mg PER977 or placebo administered following heparin sodium |
| Cohort 3 | Experimental | Drug: PER977, Drug: Placebo, Drug: Heparin Sodium300 mg PER977 or placebo administered following heparin sodium |
| Cohort 4 | Experimental | Drug: PER977, Drug: Placebo, Drug: Heparin Sodium400 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 |
| Cohort 5 | Experimental | Drug: PER977, Drug: Placebo, Drug: Heparin Sodium500 mg PER977 or placebo will be administered following heparin sodium injection |
| Cohort 6 | Experimental | Drug: PER977, Drug: Placebo, Drug: Heparin Sodium600 mg PER977 or placebo will be administered following heparin sodium injection |
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 as judged by the Investigator.
- 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 (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).
- History of unexplained syncope
- 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
- 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 heparin-induced anticoagulation | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| PlaceboReversal of heparin-induced anticoagulation | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| Heparin Sodium | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
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
1 secondary outcome
Safety and tolerability of PER977 administered following heparin
Time frame: Single day dosing
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.
Barbara Lomeli, 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 Heparin Sodium 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?
Effect of PER977 on reversal of heparin anticoagulation (time frame: Single day dosing). 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.