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 1 of 4) (NCT NCT01758432)
NCT ID: NCT01758432
Last Updated: 2023-08-07
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
54 participants
Primary outcome timeframe
Baseline to 2 minutes following the end of andexanet/placebo administration
Results posted on
2023-08-07
Participant Flow
Subject recruitment occurred at investigative site in the US between November 2012 through October 2013
Apixaban was administered orally at 5 mg twice daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment (andexanet:placebo, 6:3) 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 apixaban.
Participant milestones
| Measure |
Module 1 Placebo
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 180 mg Bolus)
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
18
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
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 1 of 4)
Baseline characteristics by cohort
| Measure |
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 7.69 • n=99 Participants
|
33.7 years
STANDARD_DEVIATION 8.48 • n=107 Participants
|
35.0 years
STANDARD_DEVIATION 7.32 • n=206 Participants
|
33.8 years
STANDARD_DEVIATION 5.78 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 9.50 • n=31 Participants
|
32.5 years
STANDARD_DEVIATION 8.60 • n=30 Participants
|
31.8 years
STANDARD_DEVIATION 6.97 • n=3 Participants
|
33.2 years
STANDARD_DEVIATION 7.42 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
46 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 54 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 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
|
-93.07 Percent change in anti-fXa activity
Standard Deviation 1.765
|
-92.82 Percent change in anti-fXa activity
Standard Deviation 1.267
|
-7.06 Percent change in anti-fXa activity
Standard Deviation 10.801
|
-67.79 Percent change in anti-fXa activity
Standard Deviation 7.731
|
-78.51 Percent change in anti-fXa activity
Standard Deviation 3.815
|
-95.04 Percent change in anti-fXa activity
Standard Deviation 1.375
|
-94.03 Percent change in anti-fXa activity
Standard Deviation 1.870
|
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 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration
|
196.29 Percent change in thrombin generation
Standard Deviation 65.406
|
191.77 Percent change in thrombin generation
Standard Deviation 122.385
|
28.11 Percent change in thrombin generation
Standard Deviation 36.871
|
76.58 Percent change in thrombin generation
Standard Deviation 47.729
|
137.50 Percent change in thrombin generation
Standard Deviation 67.528
|
120.95 Percent change in thrombin generation
Standard Deviation 91.301
|
222.56 Percent change in thrombin generation
Standard Deviation 95.671
|
SECONDARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 54 subjects who received apixaban were included in the apixaban pharmacokinetics (PK) analysis
Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay.
Outcome measures
| Measure |
Module 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration
|
-89 % change in unbound apixaban concentrat.
Standard Deviation 3
|
-84 % change in unbound apixaban concentrat.
Standard Deviation 6
|
-5 % change in unbound apixaban concentrat.
Standard Deviation 14
|
-51 % change in unbound apixaban concentrat.
Standard Deviation 12
|
-54 % change in unbound apixaban concentrat.
Standard Deviation 7
|
-72 % change in unbound apixaban concentrat.
Standard Deviation 7
|
-79 % change in unbound apixaban concentrat.
Standard Deviation 6
|
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: 36 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. Cmax was taken directly from the raw data.
Outcome measures
| Measure |
Module 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Andexanet Maximum Observed Plasma Concentration (Cmax)
|
88000 ng/mL
Standard Deviation 9010
|
90800 ng/mL
Standard Deviation 29600
|
NA ng/mL
Standard Deviation NA
Andexanet not administered (placebo group)
|
21200 ng/mL
Standard Deviation 2400
|
42800 ng/mL
Standard Deviation 5620
|
81400 ng/mL
Standard Deviation 10900
|
93300 ng/mL
Standard Deviation 18400
|
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: 36 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 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Andexanet Time of Maximum Observed Plasma Concentration (Tmax)
|
0.27 hr
Interval 0.26 to 0.31
|
0.28 hr
Interval 0.272 to 0.29
|
NA hr
Andexanet was not administered (placebo group)
|
0.07 hr
Interval 0.07 to 0.08
|
0.15 hr
Interval 0.14 to 0.3
|
0.27 hr
Interval 0.26 to 0.29
|
0.43 hr
Interval 0.25 to 0.52
|
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: 36 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 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Andexanet Total Volume of Distribution (Vss)
|
NA L
Standard Deviation NA
Vss calculations do not take into account the 45 minute intervals between doses.
|
4.01 L
Standard Deviation 0.951
|
NA L
Standard Deviation NA
Andexanet not administered (placebo group)
|
6.97 L
Standard Deviation 1.42
|
6.18 L
Standard Deviation 1.31
|
6.26 L
Standard Deviation 0.742
|
5.11 L
Standard Deviation 1.64
|
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: 36 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 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )
|
155000 ng*hr/mL
Standard Deviation 16200
|
213000 ng*hr/mL
Standard Deviation 33900
|
NA ng*hr/mL
Standard Deviation NA
Andexanet was not administered (placebo group)
|
23400 ng*hr/mL
Standard Deviation 3460
|
49200 ng*hr/mL
Standard Deviation 3960
|
93500 ng*hr/mL
Standard Deviation 15500
|
131000 ng*hr/mL
Standard Deviation 20500
|
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: 36 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 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Andexanet Total Systemic Clearance (CL)
|
NA L
Standard Deviation NA
Not determined as CL
|
4.30 L
Standard Deviation 0.608
|
NA L
Standard Deviation NA
Andexanet not administered (placebo group)
|
3.93 L
Standard Deviation 0.634
|
4.29 L
Standard Deviation 0.331
|
4.60 L
Standard Deviation 0.814
|
4.70 L
Standard Deviation 0.887
|
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: 36 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 electro chemiluminescent 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 1 (420 mg Bolus + 180 mg Bolus)
n=6 Participants
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
Module 1 Placebo
n=18 Participants
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 Participants
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 Participants
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 Participants
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 Participants
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
|---|---|---|---|---|---|---|---|
|
Andexanet Apparent Terminal Elimination Half-life (t1/2)
|
5.79 hr
Standard Deviation 2.00
|
6.45 hr
Standard Deviation 0.41
|
NA hr
Standard Deviation NA
Andexanet was not administered (placebo group)
|
5.51 hr
Standard Deviation 0.84
|
5.12 hr
Standard Deviation 1.66
|
5.02 hr
Standard Deviation 2.02
|
4.35 hr
Standard Deviation 1.40
|
Adverse Events
Module 1 Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Module 1 ( 90 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Module 1 (210 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Module 1 (420 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Module 1 (420 mg Bolus + 180 mg Infusion)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Module 1 (420 mg Bolus + 180 mg Bolus)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Module 1 (420 mg Bolus + 480 mg Infusion)
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 1 Placebo
n=18 participants at risk
Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
|
Module 1 ( 90 mg)
n=6 participants at risk
90 mg andexanet IV bolus administered over 3 minutes (\~30 mg/min)
|
Module 1 (210 mg)
n=6 participants at risk
210 mg andexanet IV bolus administered over 10 minutes (\~30 mg/min) 420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg)
n=6 participants at risk
420 mg andexanet IV bolus administered over 15 minutes (\~30 mg/min)
|
Module 1 (420 mg Bolus + 180 mg Infusion)
n=6 participants at risk
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 180 mg Bolus)
n=6 participants at risk
420 mg andexanet/placebo IV bolus administered over \~14 minutes (\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\~ 6 minutes (\~30 mg/min) \[total 600 mg\]
|
Module 1 (420 mg Bolus + 480 mg Infusion)
n=6 participants at risk
420 mg andexanet IV bolus administered over \~14 minutes (\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \[total 900 mg\]
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Eye disorders
Ocular hyperaemmia
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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 lower
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Haematochezia
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Chills
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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%
0/18 • ~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.
|
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 cold
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
16.7%
3/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
22.2%
4/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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 paraesthesia
|
0.00%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
11.1%
2/18 • ~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.
|
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.
|
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.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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 haematoma
|
11.1%
2/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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.
|
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%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Back pain
|
11.1%
2/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Flank pain
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Muscle twitching
|
0.00%
0/18 • ~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.
|
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
Muscular weakness
|
0.00%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Dysgeusia
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
11.1%
2/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Hypoaesthesia
|
0.00%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Presyncope
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Epistaxis
|
0.00%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Rhinitis allergic
|
0.00%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
11.1%
2/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
Heat rash
|
0.00%
0/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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
|
5.6%
1/18 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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.
|
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 generalized
|
0.00%
0/18 • ~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.
|
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