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Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)

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ClinicalTrials.gov Identifier: NCT03551743
Recruitment Status : Completed
First Posted : June 11, 2018
Results First Posted : August 31, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy Volunteers
Interventions Combination Product: PRT064445/Edoxaban
Combination Product: Placebo/Edoxaban
Drug: Placebo
Enrollment 28
Recruitment Details Subject recruitment occurred at investigative site in the US between March 2014 through August 2015
Pre-assignment Details 28 subjects were enrolled in Module 4. Edoxaban was administered 60 mg orally once daily for 6 days in an open label fashion. Andexanet/placebo was administered intravenously (IV) on Day 6 such that they ended at 3 hours (Cohorts 1 and 2) or 5 hours (Cohort 3) after the last dose of edoxaban.
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion. 600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min) 800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg] 800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Period Title: Overall Study
Started 10 6 6 6
Completed 8 6 6 6
Not Completed 2 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Withdrawal by Subject             1             0             0             0
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg) Total
Hide Arm/Group Description Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion. 600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min) 800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg] 800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min) Total of all reporting groups
Overall Number of Baseline Participants 10 6 6 6 28
Hide Baseline Analysis Population Description
28 subjects were enrolled in Module 4 and 26 subjects completed the study follow-up
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 6 participants 6 participants 6 participants 28 participants
30.2  (8.35) 38.8  (8.61) 31.3  (8.82) 35.5  (8.55) 33.4  (8.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 6 participants 6 participants 28 participants
Female
2
  20.0%
2
  33.3%
1
  16.7%
3
  50.0%
8
  28.6%
Male
8
  80.0%
4
  66.7%
5
  83.3%
3
  50.0%
20
  71.4%
1.Primary Outcome
Title Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
Hide Description 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)
Time Frame Baseline to 2 minutes following the end of andexanet/placebo administration
Hide Outcome Measure Data
Hide Analysis Population Description
26 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Mean (Standard Deviation)
Unit of Measure: Percent change in anti-fXa activity
-27.64  (13.091) -51.71  (15.95) -72.60  (8.35) -82.04  (6.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (600mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0344
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value -65.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (800 mg Bolus + 480 mg Infusion)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value -92.38
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (800 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value -46.26
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration
Hide Description Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.
Time Frame Baseline to 2 minutes following the end of andexanet/placebo administration
Hide Outcome Measure Data
Hide Analysis Population Description
26 subjects who received andexanet or placebo were included in the PD analysis
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Mean (Standard Deviation)
Unit of Measure: Percent change in thrombin generation
18.09  (20.716) 143.37  (31.742) 252.92  (115.318) 238.16  (82.287)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (600mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value 88722.37
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (800 mg Bolus + 480 mg Infusion)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value 151500.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (800 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value 198560.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Efficacy: Percent Change From Baseline in Unbound Edoxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration
Hide Description Unbound edoxaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for edoxaban was determined by a rapid equilibrium dialysis method followed by Liquid chromatography- Mass Spectrometry.
Time Frame Baseline to 2 minutes following the end of andexanet/placebo administration
Hide Outcome Measure Data
Hide Analysis Population Description
26 subjects who received edoxaban were included in the edoxaban pharmacokinetics (PK) analysis
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Mean (Standard Deviation)
Unit of Measure: Percent change in unbound edoxaban conce
-17  (15) -56  (7) -66  (9) -76  (13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (600mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1874
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value -76.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (800 mg Bolus + 480 mg Infusion)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.386
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value -27.98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Module 4 Placebo, Module 4 (800 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means (Difference)
Estimated Value -49.99
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Andexanet Maximum Observed Plasma Concentration (Cmax)
Hide Description Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Maximum observed plasma concentration was taken directly from the raw data.
Time Frame Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
18 subjects who received andexanet are included in the PK analysis for andexanet
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
NA [1]   (NA) 111000  (20000) 176000  (16600) 235000  (106000)
[1]
Andexanet was not administered (placebo group)
5.Secondary Outcome
Title Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )
Hide Description Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach
Time Frame Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
18 subjects who received andexanet are included in the PK analysis for andexanet
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
NA [1]   (NA) 129000  (26900) 315000  (39600) 241000  (77200)
[1]
Andexanet not administered (placebo group)
6.Secondary Outcome
Title Andexanet Time of Maximum Observed Plasma Concentration (Tmax)
Hide Description Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.
Time Frame Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
18 subjects who received andexanet are included in the PK analysis for andexanet
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Median (Full Range)
Unit of Measure: hr
NA [1] 
(NA to NA)
0.38
(0.36 to 0.40)
0.49
(0.49 to 0.74)
0.50
(0.49 to 0.85)
[1]
Andexanet not administered (placebo group)
7.Secondary Outcome
Title Andexanet Apparent Terminal Elimination Half-life (t1/2)
Hide Description Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration–time curve.
Time Frame Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
18 subjects who received andexanet are included in the PK analysis for andexanet
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr
NA [1]   (NA) 8.21  (6.08) 6.90  (1.57) 8.06  (3.24)
[1]
Andexanet not administered (placebo group)
8.Secondary Outcome
Title Andexanet Total Systemic Clearance (CL)
Hide Description Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach.
Time Frame Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
18 subjects who received andexanet are included in the PK analysis for andexanet
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Mean (Standard Deviation)
Unit of Measure: L/hr
NA [1]   (NA) 4.80  (0.872) NA [2]   (NA) 3.57  (0.995)
[1]
Andexanet not administered (placebo group)
[2]
Not calculable, since parameter does not take into account the 60 minutes interval
9.Secondary Outcome
Title Andexanet Total Volume of Distribution (Vss)
Hide Description Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.
Time Frame Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description:
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min)
800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg]
800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
Overall Number of Participants Analyzed 8 6 6 6
Mean (Standard Deviation)
Unit of Measure: L
NA [1]   (NA) 6.16  (1.96) NA [2]   (NA) 4.34  (1.61)
[1]
Andexanet not administered (placebo group)
[2]
Not calculable, since parameter does not take into account the 60 minutes interval
Time Frame ~7 weeks
Adverse Event Reporting Description Only subjects who received at least one dose of study drug were included in the safety analysis.
 
Arm/Group Title Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Hide Arm/Group Description Placebo administered IV as a bolus or a bolus followed by continuous infusion. 600 mg andexanet IV bolus administered over ~20 minutes (~30 mg/min) 800 mg andexanet IV bolus over ~27 minutes (~30 mg/min) followed immediately by a continuous infusion of 480 mg (8 mg/min over 60 min) [total 1280 mg] 800 mg andexanet IV bolus administered over ~27 minutes (~30 mg/min)
All-Cause Mortality
Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Module 4 Placebo Module 4 (600mg) Module 4 (800 mg Bolus + 480 mg Infusion) Module 4 (800 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/8 (37.50%)   5/6 (83.33%)   3/6 (50.00%)   3/6 (50.00%) 
Blood and lymphatic system disorders         
Anemia  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders         
Gingival pain  1  1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gingival swelling  1  1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hematochezia  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Nausea  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders         
Chest discomfort  1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Fatigue  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Thirst  1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Vessel puncture site hematoma  1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Vessel puncture site pain  1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Infections and infestations         
Respiratory tract infection  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Upper respiratory tract infection  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications         
Infusion related reaction  1  1/8 (12.50%)  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%) 
Investigations         
White blood cells urine positive  1  1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/8 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
Joint swelling  1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal pain  1  1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Neck pain  1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Pain in extremity  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders         
Dizziness  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Headache  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%) 
Presyncope  1  1/8 (12.50%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
Ecchymosis  1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Pruritus  1  1/8 (12.50%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Rash papular  1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Vascular disorders         
Pallor  1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Conducted in healthy volunteers at Clinical Research Organization.
Results Point of Contact
Name/Title: Head of Clinical Development
Organization: Portola Pharmaceuticals, Inc.
Phone: 650-246-7000
Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03551743     History of Changes
Other Study ID Numbers: 12-502 Module 4
First Submitted: May 15, 2018
First Posted: June 11, 2018
Results First Submitted: June 26, 2018
Results First Posted: August 31, 2018
Last Update Posted: September 28, 2018