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 3 of 4) (NCT NCT03551730)
NCT ID: NCT03551730
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
27 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 August 2013 through November 2013
Enoxaparin was administered subcutaneously at 40 mg once daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment intravenously on Day 6; such that they ended at 3 hours after the last dose of enoxaparin.
Participant milestones
| Measure |
Placebo
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 5.59 • n=39 Participants
|
33.2 years
STANDARD_DEVIATION 8.30 • n=41 Participants
|
32.5 years
STANDARD_DEVIATION 5.09 • n=35 Participants
|
35.7 years
STANDARD_DEVIATION 8.66 • n=31 Participants
|
33.7 years
STANDARD_DEVIATION 6.60 • n=146 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 26 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis
Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Efficacy:Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration Activity
|
-3.57 Percent change in anti-fXa activity
Standard Deviation 12.80
|
-70.80 Percent change in anti-fXa activity
Standard Deviation 6.98
|
-60.83 Percent change in anti-fXa activity
Standard Deviation 8.39
|
-69.85 Percent change in anti-fXa activity
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administrationPopulation: 26 subjects who received andexanet or placebo were included in the PD analysis
Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration
|
3.48 Percent change in thrombin generation
Standard Deviation 15.162
|
36.34 Percent change in thrombin generation
Standard Deviation 15.127
|
107.48 Percent change in thrombin generation
Standard Deviation 73.301
|
72.7 Percent change in thrombin generation
Standard Deviation 74.301
|
SECONDARY outcome
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.Population: 18 subjects who received andexanet were included in the andexanet pharmacokinetics (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 |
Placebo
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Maximum Observed Plasma Concentration (Cmax)
|
—
|
32000 ng/mL
Standard Deviation 7320
|
55800 ng/mL
Standard Deviation 6050
|
42700 ng/mL
Standard Deviation 14400
|
SECONDARY outcome
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.Population: 18 subjects who received andexanet 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 |
Placebo
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )
|
—
|
33600 ng*hr/mL
Standard Deviation 4280
|
63900 ng*hr/mL
Standard Deviation 8880
|
40900 ng*hr/mL
Standard Deviation 12300
|
SECONDARY outcome
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.Population: 18 subjects who received andexanet 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 |
Placebo
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Time of Maximum Observed Plasma Concentration (Tmax)
|
—
|
0.18 hr
Interval 0.16 to 0.35
|
0.29 hr
Interval 0.27 to 0.54
|
0.17 hr
Interval 0.17 to 0.19
|
SECONDARY outcome
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.Population: 18 subjects who received andexanet 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 |
Placebo
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Apparent Terminal Elimination Half-life (t1/2)
|
—
|
5.28 hr
Standard Deviation 1.99
|
6.11 hr
Standard Deviation 2.34
|
8.36 hr
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.Population: 18 subjects who received andexanet 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.
Outcome measures
| Measure |
Placebo
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Total Systemic Clearance (CL)
|
—
|
6.34 L/hr
Standard Deviation 0.870
|
6.69 L/hr
Standard Deviation 0.991
|
5.56 L/hr
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.Population: 18 subjects who received andexanet 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 |
Placebo
Placebo administered intravenously (IV) as a bolus.
|
Module 3 (210 mg Bolus) Original
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Bolus) Original
n=6 Participants
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg) Lyophilized
n=6 Participants
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Andexanet Total Volume of Distribution (Vss)
|
—
|
9.86 L
Standard Deviation 2.61
|
9.62 L
Standard Deviation 1.13
|
9.69 L
Standard Deviation 4.16
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Module 3 (210 mg Andexanet) Original Formulation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Module 3 (420 mg Andexanet) Original Forumulation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Module 3 (210 mg Andexanet ) Lyophilized
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 |
Placebo
n=8 participants at risk
Placebo was administered intravenously (IV) as a bolus
|
Module 3 (210 mg Andexanet) Original Formulation
n=6 participants at risk
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
Module 3 (420 mg Andexanet) Original Forumulation
n=6 participants at risk
420 mg andexanet IV bolus over 14 minutes (\~30 mg/min) 420 mg andexanet IV bolus over 14 minutes (\~30 mg/min)
|
Module 3 (210 mg Andexanet ) Lyophilized
n=6 participants at risk
210 mg andexanet IV bolus over 7 minutes (\~30 mg/min) 210 mg andexanet IV bolus over 7 minutes (\~30 mg/min)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
37.5%
3/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Thirst
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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
Upper respiratory tract infection
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Post procedural hematoma
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
2/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
25.0%
2/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
33.3%
2/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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
Arthralgia
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety 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
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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
Paresthesia
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
16.7%
1/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
12.5%
1/8 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/6 • ~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
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