Study of Ciraparantag for Reversal of Anticoagulation Induced by Apixaban or Rivaroxaban in Healthy Adults

• Status: Not yet recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs in generally healthy adults as measured primarily by an automated coagulometer device.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

1. Provide written informed consent.

2. 18 to 75 years of age.

3. Be in generally good health with BMI 18 to 32 kg/m2.

4. If female, be surgically sterile or post-menopausal, or using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive).

5. If male, be surgically sterile, or agree to use appropriate contraception.

6. Have suitable venous access for multiple venipunctures.

Exclusion Criteria:

1. Have any of the following findings at Screening:

1. Hemoglobin , hematocrit, platelets, PT, aPTT, fibrinogen, triglycerides, or bilirubin

2. Serum creatinine >1.5 mg/dL or known renal disease

3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x the upper limit of normal, or known liver disease

4. Positive viral screen for HBV, HCV, or HIV

5. Positive pregnancy test (females)

6. Positive drug, tobacco or alcohol screen

7. Any clinically significant findings on 12-lead ECG or urinalysis

2. Have a personal or family history of clotting disorder or hematologic abnormality.

3. Have a history of unexplained syncope.

4. Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure, vaginal delivery, peptic ulcer or GI bleeding.

5. Have received any blood product or anticoagulant, or donated any blood, within 3 months prior to Screening.

6. Have a history of recurrent minor bleeding episodes.

7. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).

8. Have used any tobacco or nicotine-containing products within 3 months prior to Screening.

9. Have used any systemic prescription or non-prescription drugs within 14 days prior to Day 1.

10. If female, be pregnant, breastfeeding, or planning to become pregnant during the study.

11. Have received ciraparantag in any prior clinical study.

12. Have received another investigational drug within 5 half-lives or 30 days, whichever is longer, prior to Day 1.

13. Known allergy to apixaban or rivaroxaban.