Trial Outcomes & Findings for 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) (NCT NCT03551743)
NCT ID: NCT03551743
Last Updated: 2023-02-21
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline to 2 minutes following the end of andexanet/placebo administration
Results posted on
2023-02-21
Participant Flow
Subject recruitment occurred at investigative site in the US between March 2014 through August 2015
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.
Participant milestones
| Measure |
Module 4 Placebo
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
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) \[total 1280 mg\]
|
Module 4 (800 mg)
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Module 4 Placebo
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
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) \[total 1280 mg\]
|
Module 4 (800 mg)
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Module 4 Placebo
n=10 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 8.35 • n=99 Participants
|
38.8 years
STANDARD_DEVIATION 8.61 • n=107 Participants
|
31.3 years
STANDARD_DEVIATION 8.82 • n=206 Participants
|
35.5 years
STANDARD_DEVIATION 8.55 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 8.79 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 26 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis
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)
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
|
-27.64 Percent change in anti-fXa activity
Standard Deviation 13.091
|
-51.71 Percent change in anti-fXa activity
Standard Deviation 15.95
|
-72.60 Percent change in anti-fXa activity
Standard Deviation 8.35
|
-82.04 Percent change in anti-fXa activity
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 26 subjects who received andexanet or placebo were included in the PD analysis
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.
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration
|
18.09 Percent change in thrombin generation
Standard Deviation 20.716
|
143.37 Percent change in thrombin generation
Standard Deviation 31.742
|
252.92 Percent change in thrombin generation
Standard Deviation 115.318
|
238.16 Percent change in thrombin generation
Standard Deviation 82.287
|
SECONDARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 26 subjects who received edoxaban were included in the edoxaban pharmacokinetics (PK) analysis
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.
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Unbound Edoxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration
|
-17 Percent change in unbound edoxaban conce
Standard Deviation 15
|
-56 Percent change in unbound edoxaban conce
Standard Deviation 7
|
-66 Percent change in unbound edoxaban conce
Standard Deviation 9
|
-76 Percent change in unbound edoxaban conce
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 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.Population: 18 subjects who received andexanet are included in the PK analysis for andexanet
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.
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Maximum Observed Plasma Concentration (Cmax)
|
NA ng/mL
Standard Deviation NA
Andexanet was not administered (placebo group)
|
111000 ng/mL
Standard Deviation 20000
|
176000 ng/mL
Standard Deviation 16600
|
235000 ng/mL
Standard Deviation 106000
|
SECONDARY outcome
Timeframe: 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.Population: 18 subjects who received andexanet are included in the PK analysis for andexanet
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
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )
|
NA ng*hr/mL
Standard Deviation NA
Andexanet not administered (placebo group)
|
129000 ng*hr/mL
Standard Deviation 26900
|
315000 ng*hr/mL
Standard Deviation 39600
|
241000 ng*hr/mL
Standard Deviation 77200
|
SECONDARY outcome
Timeframe: 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.Population: 18 subjects who received andexanet are included in the PK analysis for andexanet
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.
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Time of Maximum Observed Plasma Concentration (Tmax)
|
NA hr
Andexanet not administered (placebo group)
|
0.38 hr
Interval 0.36 to 0.4
|
0.49 hr
Interval 0.49 to 0.74
|
0.50 hr
Interval 0.49 to 0.85
|
SECONDARY outcome
Timeframe: 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.Population: 18 subjects who received andexanet are included in the PK analysis for andexanet
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.
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Apparent Terminal Elimination Half-life (t1/2)
|
NA hr
Standard Deviation NA
Andexanet not administered (placebo group)
|
8.21 hr
Standard Deviation 6.08
|
6.90 hr
Standard Deviation 1.57
|
8.06 hr
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: 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.Population: 18 subjects who received andexanet are included in the PK analysis for andexanet
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.
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Total Systemic Clearance (CL)
|
NA L/hr
Standard Deviation NA
Andexanet not administered (placebo group)
|
4.80 L/hr
Standard Deviation 0.872
|
NA L/hr
Standard Deviation NA
Not calculable, since parameter does not take into account the 60 minutes interval
|
3.57 L/hr
Standard Deviation 0.995
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Module 4 Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 Participants
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 Participants
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 Participants
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Total Volume of Distribution (Vss)
|
NA L
Standard Deviation NA
Andexanet not administered (placebo group)
|
6.16 L
Standard Deviation 1.96
|
NA L
Standard Deviation NA
Not calculable, since parameter does not take into account the 60 minutes interval
|
4.34 L
Standard Deviation 1.61
|
Adverse Events
Module 4 Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Module 4 (600mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Module 4 (800 mg Bolus + 480 mg Infusion)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Module 4 (800 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Module 4 Placebo
n=8 participants at risk
Placebo administered IV as a bolus or a bolus followed by continuous infusion.
|
Module 4 (600mg)
n=6 participants at risk
600 mg andexanet IV bolus administered over \~20 minutes (\~30 mg/min)
|
Module 4 (800 mg Bolus + 480 mg Infusion)
n=6 participants at risk
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) \[total 1280 mg\]
|
Module 4 (800 mg)
n=6 participants at risk
800 mg andexanet IV bolus administered over \~27 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Gingival pain
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Gingival swelling
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Fatigue
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Thirst
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Vessel puncture site hematoma
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
33.3%
2/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Investigations
White blood cells urine positive
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
33.3%
2/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Vascular disorders
Pallor
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
Additional Information
Head of Clinical Development
Portola Pharmaceuticals, Inc.
Phone: 650-246-7000
Results disclosure agreements
- Principal investigator is a sponsor employee Conducted in healthy volunteers at Clinical Research Organization.
- Publication restrictions are in place
Restriction type: OTHER