NCT01758432

A Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy Volunteers

Completed Phase 2 Results posted Last updated 3 August 2023

What this trial tests

Phase 2 trial testing PRT064445/Apixaban in Healthy Volunteers in 54 participants. Completed in 1 September 2015.

Timeline

1 December 2012

Primary endpoint
1 September 2015

1 September 2015

Quick facts

Lead sponsor	Portola Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	54
Start date	1 December 2012
Primary completion	1 September 2015
Estimated completion	1 September 2015
Sites	1 location across United States

Drugs / interventions tested

• PRT064445/Apixaban
• Placebo/Apixaban
• Placebo

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Portola Pharmaceuticals — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
  Time frame: Baseline to 2 minutes following the end of andexanet/placebo administration
  Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)

Sponsor's own description

The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Andexanet Alfa: First Global Approval.
   Heo YA. · · 2018 · cited 77× · PMID 29926311 · DOI 10.1007/s40265-018-0940-4
2. Edoxaban: an update on the new oral direct factor Xa inhibitor.
   Bounameaux H, Camm AJ. · · 2014 · cited 67× · PMID 25034361 · DOI 10.1007/s40265-014-0261-1
3. Portal vein thrombosis in cirrhosis: Controversies and latest developments.
   Harding DJ, Perera MT, Chen F, Olliff S, et al · · 2015 · cited 64× · PMID 26078553 · DOI 10.3748/wjg.v21.i22.6769
4. Safety, pharmacokinetics, and reversal of apixaban anticoagulation with andexanet alfa.
   Siegal D, Lu G, Leeds JM, Karbarz M, et al · · 2017 · cited 59× · PMID 29296829 · DOI 10.1182/bloodadvances.2017007112
5. Reversing anticoagulant effects of novel oral anticoagulants: role of ciraparantag, andexanet alfa, and idarucizumab.
   Hu TY, Vaidya VR, Asirvatham SJ. · · 2016 · cited 58× · PMID 26937198 · DOI 10.2147/vhrm.s89130
6. Management of acute stroke in patients taking novel oral anticoagulants.
   Hankey GJ, Norrving B, Hacke W, Steiner T. · · 2014 · cited 41× · PMID 24891030 · DOI 10.1111/ijs.12295
7. Reversal of direct oral anticoagulants: a practical approach.
   Shih AW, Crowther MA. · · 2016 · cited 23× · PMID 27913536 · DOI 10.1182/asheducation-2016.1.612
8. Pharmacokinetic and pharmacodynamic evaluation of rivaroxaban: considerations for the treatment of venous thromboembolism.
   Harder S. · · 2014 · cited 23× · PMID 25698904 · DOI 10.1186/1477-9560-12-22