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 2 of 4) (NCT NCT03578146)
NCT ID: NCT03578146
Last Updated: 2023-02-22
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
48 participants
Primary outcome timeframe
Baseline to 2 minutes following the end of andexanet/placebo administration
Results posted on
2023-02-22
Participant Flow
Subject recruitment occurred at investigative site in the US between March 2013 through April 2014
Rivaroxaban was administered orally at 20 mg once daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment (andexanet or placebo) intravenously at different doses/dose regimens on Day 6, all bolus doses administered such that they ended at 3 hours after the last dose of rivaroxaban.
Participant milestones
| Measure |
Module 2 Placebo
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
15
|
5
|
5
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Module 2 Placebo
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Overall Study
Did Not Receive Treatment
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
1
|
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 2 of 4)
Baseline characteristics by cohort
| Measure |
Module 2 Placebo
n=16 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=8 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 6.69 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 3.33 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 7.25 • n=4 Participants
|
35.2 years
STANDARD_DEVIATION 5.04 • n=21 Participants
|
32.9 years
STANDARD_DEVIATION 8.10 • n=10 Participants
|
35.8 years
STANDARD_DEVIATION 6.79 • n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
39 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 45 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 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
|
22.37 Percent change in anti-fXa activity
Standard Deviation 42.247
|
-18.09 Percent change in anti-fXa activity
Standard Deviation 23.922
|
-50.59 Percent change in anti-fXa activity
Standard Deviation 22.056
|
-75.26 Percent change in anti-fXa activity
Standard Deviation 19.072
|
-88.91 Percent change in anti-fXa activity
Standard Deviation 6.098
|
-92.72 Percent change in anti-fXa activity
Standard Deviation 3.084
|
SECONDARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 45 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 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration
|
14.00 Percent change in thrombin generation
Standard Deviation 29.267
|
107.47 Percent change in thrombin generation
Standard Deviation 48.977
|
167.67 Percent change in thrombin generation
Standard Deviation 36.568
|
246.02 Percent change in thrombin generation
Standard Deviation 135.387
|
513.85 Percent change in thrombin generation
Standard Deviation 285.992
|
559.14 Percent change in thrombin generation
Standard Deviation 288.258
|
SECONDARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 45 subjects who received rivaroxaban were included in the rivaroxaban pharmacokinetics (PK) analysis
Unbound rivaroxaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for rivaroxaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay.
Outcome measures
| Measure |
Module 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Unbound Rivaroaxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration
|
-11 Percent change in unbound apixaban conc.
Standard Deviation 11
|
34 Percent change in unbound apixaban conc.
Standard Deviation 22
|
52 Percent change in unbound apixaban conc.
Standard Deviation 18
|
75 Percent change in unbound apixaban conc.
Standard Deviation 16
|
67 Percent change in unbound apixaban conc.
Standard Deviation 24
|
80 Percent change in unbound apixaban conc.
Standard Deviation 12
|
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: 30 subjects who received andexanet were included in the andexanet PK analysis
Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay.
Outcome measures
| Measure |
Module 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Andexanet Maximum Observed Plasma Concentration (Cmax)
|
NA ng/mL
Standard Deviation NA
Andexanet was not administered (placebo group)
|
50400 ng/mL
Standard Deviation 12100
|
105000 ng/mL
Standard Deviation 28500
|
110000 ng/mL
Standard Deviation 7070
|
123000 ng/mL
Standard Deviation 28900
|
161000 ng/mL
Standard Deviation 40400
|
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: 30 subjects who received andexanet were included in the andexanet PK analysis
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 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )
|
NA ng*hr/mL
Standard Deviation NA
Andexanet was not administered (placebo group)
|
51400 ng*hr/mL
Standard Deviation 7520
|
111000 ng*hr/mL
Standard Deviation 35900
|
133000 ng*hr/mL
Standard Deviation 11500
|
216000 ng*hr/mL
Standard Deviation 41300
|
429000 ng*hr/mL
Standard Deviation 85300
|
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: 30 subjects who received andexanet were included in the andexanet PK analysis
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 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Andexanet Time of Maximum Observed Plasma Concentration (Tmax)
|
NA hr
Andexanet was not administered (placebo group)
|
0.17 hr
Interval 0.16 to 0.41
|
0.36 hr
Interval 0.29 to 0.52
|
0.51 hr
Interval 0.39 to 0.83
|
0.56 hr
Interval 0.44 to 0.7
|
0.52 hr
Interval 0.49 to 0.73
|
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: 30 subjects who received andexanet were included in the andexanet PK analysis
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 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Andexanet Apparent Terminal Elimination Half-life (t1/2)
|
NA hr
Standard Deviation NA
Andexanet was not administered (placebo group)
|
4.97 hr
Standard Deviation 0.74
|
3.91 hr
Standard Deviation 0.43
|
4.54 hr
Standard Deviation 1.65
|
6.47 hr
Standard Deviation 3.59
|
4.45 hr
Standard Deviation 0.58
|
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: 30 subjects who received andexanet were included in the andexanet PK analysis
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, calculated as Dose/AUC0-inf
Outcome measures
| Measure |
Module 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Andexanet Total Systemic Clearance (CL)
|
NA L/hr
Standard Deviation NA
Andexanet was not administered (placebo group)
|
4.15 L/hr
Standard Deviation 0.556
|
4.18 L/hr
Standard Deviation 1.51
|
4.53 L/hr
Standard Deviation 0.399
|
4.58 L/hr
Standard Deviation 0.837
|
4.23 L/hr
Standard Deviation 0.808
|
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: 30 subjects who received andexanet were included in the andexanet PK analysis
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 2 Placebo
n=15 Participants
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 Participants
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 Participants
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 Participants
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Andexanet Total Volume of Distribution (Vss)
|
NA L
Standard Deviation NA
Andexanet was not administered (placebo group)
|
5.23 L
Standard Deviation 1.09
|
4.65 L
Standard Deviation 1.69
|
5.39 L
Standard Deviation 0.546
|
4.17 L
Standard Deviation 0.797
|
3.34 L
Standard Deviation 1.20
|
Adverse Events
Module 2 Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Module 2 (210 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Module 2 (420 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Module 2 (600 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Module 2 (720 mg Bolus + 240 mg Infusion)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Module 2 (800 mg Bolus + 960 mg Infusion)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Module 2 Placebo
n=15 participants at risk
Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion
|
Module 2 (210 mg)
n=6 participants at risk
210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
|
Module 2 (420 mg)
n=6 participants at risk
420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
|
Module 2 (600 mg)
n=6 participants at risk
600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
|
Module 2 (720 mg Bolus + 240 mg Infusion)
n=6 participants at risk
720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
|
Module 2 (800 mg Bolus + 960 mg Infusion)
n=6 participants at risk
800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • ~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.
|
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
Abdominal pain upper
|
6.7%
1/15 • ~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.
|
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
Abdominal tenderness
|
0.00%
0/15 • ~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.
|
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
Constipation
|
6.7%
1/15 • ~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.
|
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
Diarrhoea
|
0.00%
0/15 • ~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.
|
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
Dry mouth
|
0.00%
0/15 • ~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.
|
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
|
6.7%
1/15 • ~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.
|
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
Toothache
|
0.00%
0/15 • ~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.
|
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
Catheter site haemorrhage
|
0.00%
0/15 • ~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.
|
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
Catheter site phlebitis
|
0.00%
0/15 • ~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.
|
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
Fatigue
|
0.00%
0/15 • ~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.
|
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
Feeling cold
|
6.7%
1/15 • ~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.
|
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
Feeling hot
|
0.00%
0/15 • ~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.
|
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
Oedema peripheral
|
0.00%
0/15 • ~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.
|
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
Tenderness
|
6.7%
1/15 • ~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.
|
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
Vessel puncture site haematoma
|
6.7%
1/15 • ~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.
|
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
Vessel puncture site pain
|
6.7%
1/15 • ~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.
|
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
Vessel puncture site reaction
|
0.00%
0/15 • ~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.
|
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
Vessel puncture site swelling
|
6.7%
1/15 • ~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.
|
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
Respiratory tract infection
|
0.00%
0/15 • ~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.
|
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • ~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.
|
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
Viral infection
|
0.00%
0/15 • ~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.
|
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.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
6.7%
1/15 • ~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.
|
33.3%
2/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
50.0%
3/6 • ~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.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
20.0%
3/15 • ~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.
|
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.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/15 • ~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.
|
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
Procedural site reaction
|
13.3%
2/15 • ~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.
|
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
Thermal burn
|
0.00%
0/15 • ~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.
|
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
Wound dehiscence
|
0.00%
0/15 • ~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.
|
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
1/15 • ~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.
|
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
Musculoskeletal chest pain
|
0.00%
0/15 • ~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.
|
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
Pain in extremity
|
0.00%
0/15 • ~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.
|
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
Dizziness
|
6.7%
1/15 • ~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.
|
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 postural
|
13.3%
2/15 • ~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.
|
33.3%
2/6 • ~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.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • ~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.
|
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.
|
33.3%
2/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • ~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.
|
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
Somnolence
|
0.00%
0/15 • ~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.
|
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
Tunnel vision
|
0.00%
0/15 • ~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.
|
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.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • ~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.
|
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.
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.7%
1/15 • ~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.
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/15 • ~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.
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • ~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.
|
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
Dermatitis contact
|
20.0%
3/15 • ~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.
|
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
|
6.7%
1/15 • ~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.
|
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
Hyperhidrosis
|
6.7%
1/15 • ~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.
|
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
Ingrowing nail
|
6.7%
1/15 • ~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.
|
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
Papule
|
6.7%
1/15 • ~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.
|
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
Pruritus
|
6.7%
1/15 • ~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.
|
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
Pruritus generalised
|
0.00%
0/15 • ~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.
|
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
Rash papular
|
0.00%
0/15 • ~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.
|
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.
|
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