Phase 2
Completed N=48
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4)
Healthy Volunteers
Source: ClinicalTrials.gov NCT03578146 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration — 22.37; -18.09; -50.59; -75.26 Percent change in anti-fXa activity — p=0.0121
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration |
22.37; -18.09; -50.59; -75.26; -88.91; -92.72 | 0.0121 sig |
| SECONDARY Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration |
14.00; 107.47; 167.67; 246.02; 513.85; 559.14 | <0.0001 sig |
| SECONDARY Efficacy: Percent Change From Baseline in Unbound Rivaroaxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration |
-11; 34; 52; 75; 67; 80 | 0.002 sig |
| SECONDARY Andexanet Maximum Observed Plasma Concentration (Cmax) |
NA; 50400; 105000; 110000; 123000; 161000 | — |
| SECONDARY Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf ) |
NA; 51400; 111000; 133000; 216000; 429000 | — |
| SECONDARY Andexanet Time of Maximum Observed Plasma Concentration (Tmax) |
NA; 0.17; 0.36; 0.51; 0.56; 0.52 | — |
| SECONDARY Andexanet Apparent Terminal Elimination Half-life (t1/2) |
NA; 4.97; 3.91; 4.54; 6.47; 4.45 | — |
| SECONDARY Andexanet Total Systemic Clearance (CL) |
NA; 4.15; 4.18; 4.53; 4.58; 4.23 | — |
| SECONDARY Andexanet Total Volume of Distribution (Vss) |
NA; 5.23; 4.65; 5.39; 4.17; 3.34 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy men or women between the ages of 18 and 45 years old
Exclusion Criteria
- History (including family history) or symptoms of, or risk factors for bleeding
- History (including family history) of or risk factors for a hypercoagulable or thrombotic condition
- Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants
- History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing.
Data sourced from ClinicalTrials.gov (NCT03578146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.