PK and PD of Single, Escalating Doses of PER977 Following Enoxaparin

NCT02206100 | Completed Phase 1

• 1 other identifier: PER977-01-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

PER977 administration following a single dose of enoxaparin

Conditions

Healthy

Keywords

PER977; enoxaparin; anticoagulation reversal; whole blood clotting time

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  Assessment of the number of subjects who experience adverse events and the number and type of adverse events

  1 day

Secondary Outcomes (3)

• Reversal of enoxaparin anticoagulation

  1 day

• Pharmacokinetics of enoxaparin

  1 day

• Pharmacokinetics of PER977 and its metabolite

  2 days

Study Arms (4)

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

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

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

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)

Drug: PER977; Drug: Placebo; Drug: enoxaparin

Interventions

PER977 DRUG

reversal of edoxaban-induced anticoagulation

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

Reversal of edoxaban-induced anticoagulation

Cohort 1; Cohort 2; Cohort 3; Cohort 4

enoxaparin DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.: lead

Study Sites (1)

Quintiles

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Interventions

PER977; Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Scott Rasmussen, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: August 1, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 21, 2020

Record last verified: 2017-11

Locations

US (1)