Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants (NCT NCT04448561)
NCT ID: NCT04448561
Last Updated: 2024-11-21
Results Overview
Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
From first dose of study drug up to end of study visit (up to day 25)
Results posted on
2024-11-21
Participant Flow
Participants who were recreational opioid users were enrolled in this study. Participants were enrolled in one site in the United States.
Eligible participants were randomized to ASP8062 or placebo using 2:1 ratio according to the randomization schedule. Participants who met the inclusion criteria and met none of the exclusion criteria were enrolled. A total of 54 participants were screened, out of which 30 participants failed screening.
Participant milestones
| Measure |
ASP8062 in Combination With Morphine
Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
COMPLETED
|
15
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ASP8062 in Combination With Morphine
Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|
|
Overall Study
Noncompliance
|
1
|
0
|
Baseline Characteristics
Safety Analysis Set (SAF) with baseline value taken at Day 9. SAF included all participants randomly assigned to ASP8062 or placebo and who took at least 1 dose of ASP8062 or placebo. One participant from arm ASP8062 discontinued from study on day 2.
Baseline characteristics by cohort
| Measure |
ASP8062 in Combination With Morphine
n=16 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 8.9 • n=16 Participants
|
35.4 years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
32.7 years
STANDARD_DEVIATION 9.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=16 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=16 Participants
|
5 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=16 Participants
|
8 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=16 Participants
|
5 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=16 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Blood Oxygen Saturation (SpO2)
|
98.1 Percentage of oxygen saturation
STANDARD_DEVIATION 1.0 • n=16 Participants
|
98.8 Percentage of oxygen saturation
STANDARD_DEVIATION 0.9 • n=8 Participants
|
98.3 Percentage of oxygen saturation
STANDARD_DEVIATION 1.0 • n=24 Participants
|
|
End Tidal Carbon Dioxide (CO2)
|
37.1 millimeter of mercury (mmHg)
STANDARD_DEVIATION 3.1 • n=15 Participants • Safety Analysis Set (SAF) with baseline value taken at Day 9. SAF included all participants randomly assigned to ASP8062 or placebo and who took at least 1 dose of ASP8062 or placebo. One participant from arm ASP8062 discontinued from study on day 2.
|
36.3 millimeter of mercury (mmHg)
STANDARD_DEVIATION 2.2 • n=8 Participants • Safety Analysis Set (SAF) with baseline value taken at Day 9. SAF included all participants randomly assigned to ASP8062 or placebo and who took at least 1 dose of ASP8062 or placebo. One participant from arm ASP8062 discontinued from study on day 2.
|
36.8 millimeter of mercury (mmHg)
STANDARD_DEVIATION 2.8 • n=23 Participants • Safety Analysis Set (SAF) with baseline value taken at Day 9. SAF included all participants randomly assigned to ASP8062 or placebo and who took at least 1 dose of ASP8062 or placebo. One participant from arm ASP8062 discontinued from study on day 2.
|
PRIMARY outcome
Timeframe: From first dose of study drug up to end of study visit (up to day 25)Population: The analysis population was the SAF, which consisted of all participants randomly assigned to investigational product (ASP8062 or placebo) and who took at least 1 dose of investigational product (ASP8062 or placebo).
Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.
Outcome measures
| Measure |
ASP8062
n=16 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
TEAE
|
7 Participants
|
11 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related TEAE
|
6 Participants
|
11 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug related TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAE leading to withdrawal of treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related TEAE leading to withdrawal of treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to day 25Population: The analysis population was the SAF.
The C-SSRS is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants with at least one affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported.
Outcome measures
| Measure |
ASP8062
n=16 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Number of Participants With At Least One Event of Suicidal Ideation And/or Suicidal Behavior as Assessed by The Columbia-Suicide Severity Rating Scale (C-SSRS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and predose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and predose Day 10Population: SAF population with available data at each time point.
The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose
|
0.4 percentage of oxygen saturation
Standard Deviation 1.3
|
0.3 percentage of oxygen saturation
Standard Deviation 1.2
|
-0.5 percentage of oxygen saturation
Standard Deviation 0.8
|
-0.6 percentage of oxygen saturation
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 1 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 1 hour postdose Day 10Population: SAF population with available data at each time point.
The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose
|
0.1 percentage of oxygen saturation
Standard Deviation 1.4
|
-0.7 percentage of oxygen saturation
Standard Deviation 1.4
|
-0.5 percentage of oxygen saturation
Standard Deviation 1.4
|
-1.4 percentage of oxygen saturation
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 2 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 2 hour postdose Day 10Population: SAF population with available data at each time point.
The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose
|
-0.1 percentage of oxygen saturation
Standard Deviation 1.2
|
-0.5 percentage of oxygen saturation
Standard Deviation 1.6
|
-0.9 percentage of oxygen saturation
Standard Deviation 1.1
|
-0.6 percentage of oxygen saturation
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 4 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 4 hour postdose Day 10Population: SAF population with available data at each time point.
The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose
|
0.1 percentage of oxygen saturation
Standard Deviation 1.5
|
-0.2 percentage of oxygen saturation
Standard Deviation 1.1
|
-0.5 percentage of oxygen saturation
Standard Deviation 1.1
|
-1.0 percentage of oxygen saturation
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 8 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 8 hour postdose Day 10Population: SAF population with available data at each time point.
The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose
|
0.0 percentage of oxygen saturation
Standard Deviation 1.6
|
-0.5 percentage of oxygen saturation
Standard Deviation 2.3
|
-1.1 percentage of oxygen saturation
Standard Deviation 1.8
|
-0.5 percentage of oxygen saturation
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 12 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 12 hour postdose Day 10Population: SAF population with available data at each time point.
The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose
|
-0.4 percentage of oxygen saturation
Standard Deviation 1.6
|
-0.5 percentage of oxygen saturation
Standard Deviation 1.3
|
-1.5 percentage of oxygen saturation
Standard Deviation 1.8
|
-1.3 percentage of oxygen saturation
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and predose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and predose Day 10Population: SAF population with available data at each time point.
End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose
|
NA mmHg
Standard Deviation NA
predose CO2 assessment was not performed for this group on Day 9.
|
-1.0 mmHg
Standard Deviation 2.4
|
NA mmHg
Standard Deviation NA
predose CO2 assessment was not performed for this group on Day 9.
|
0.5 mmHg
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 1 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 1 hour postdose Day 10Population: SAF population with available data at each time point.
End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose
|
-0.9 mmHg
Standard Deviation 2.4
|
0.7 mmHg
Standard Deviation 2.3
|
-0.4 mmHg
Standard Deviation 4.4
|
2.5 mmHg
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 2 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 2 hour postdose Day 10Population: SAF population with available data at each time point.
End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose
|
-1.1 mmHg
Standard Deviation 2.5
|
2.5 mmHg
Standard Deviation 3.2
|
-1.0 mmHg
Standard Deviation 1.9
|
4.1 mmHg
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 4 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 4 hour postdose Day 10Population: SAF population with available data at each time point.
End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose
|
-0.8 mmHg
Standard Deviation 1.7
|
1.0 mmHg
Standard Deviation 2.6
|
0.1 mmHg
Standard Deviation 2.5
|
3.3 mmHg
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 'ASP8062' and 'Placebo': Baseline and 8 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 8 hour postdose Day 10Population: SAF population with available data at each time point.
End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
n=8 Participants
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose
|
0.2 mmHg
Standard Deviation 0.3
|
2.7 mmHg
Standard Deviation 3.3
|
2.1 mmHg
Standard Deviation 1.5
|
5.8 mmHg
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 'ASP8062': Predose, 0.25, 0.5, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 h postdose Day 9; 'ASP8062 in combination with morphine': Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 h postdose Day 10Population: The analysis population was Pharmacokinetic Analysis Set (PKAS) with available data at each time point. PKAS consisted of all participants who received at least 1 dose of ASP8062 for which concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter of ASP8062.
AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration From Time of Dosing to 24 Hours (AUC24)
|
1640 nanogram*hour per milliliter(ng*h/mL)
Standard Deviation 619
|
1640 nanogram*hour per milliliter(ng*h/mL)
Standard Deviation 589
|
—
|
—
|
SECONDARY outcome
Timeframe: 'ASP8062': Predose, 0.25, 0.5, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 h Day 9; 'ASP8062 in combination with morphine': Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 h postdose Day 10Population: The analysis population was PKAS with available data at each time point.
Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Plasma Concentration (Cmax)
|
124 nanogram per milliliter (ng/mL)
Standard Deviation 41.1
|
116 nanogram per milliliter (ng/mL)
Standard Deviation 31.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.
AUCinf was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=3 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=3 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration From Time of Dosing Extrapolated to Time Infinity (AUCinf)
|
128 ng*h/mL
Standard Deviation 43.5
|
166 ng*h/mL
Standard Deviation 13.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was PKAS.
AUClast was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=8 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)
|
160 ng*h/mL
Standard Deviation 39.8
|
158 ng*h/mL
Standard Deviation 42.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was PKAS.
Cmax was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=8 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine in Plasma: Cmax
|
41.3 ng/mL
Standard Deviation 9.17
|
42.3 ng/mL
Standard Deviation 15.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.
AUCinf was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=7 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=6 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine-3β-D-glucuronide(M3G) (Morphine Metabolite) in Plasma: AUCinf
|
5720 ng*h/mL
Standard Deviation 980
|
6580 ng*h/mL
Standard Deviation 702
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was PKAS.
AUClast was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=8 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: AUClast
|
5340 ng*h/mL
Standard Deviation 887
|
5960 ng*h/mL
Standard Deviation 703
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was PKAS.
Cmax was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=8 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: Cmax
|
933 ng/mL
Standard Deviation 189
|
967 ng/mL
Standard Deviation 176
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was the PKAS with available at each time point. The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.
AUCinf was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=5 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=5 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUCinf
|
821 ng*h/mL
Standard Deviation 138
|
1100 ng*h/mL
Standard Deviation 212
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was the PKAS.
AUClast was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=8 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUClast
|
871 ng*h/mL
Standard Deviation 161
|
1000 ng*h/mL
Standard Deviation 165
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10Population: The analysis population was the PKAS.
Cmax was recorded from the PK plasma samples collected.
Outcome measures
| Measure |
ASP8062
n=15 Participants
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=8 Participants
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.
|
Placebo in Combination With Morphine
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: Cmax
|
184 ng/mL
Standard Deviation 37.6
|
192 ng/mL
Standard Deviation 30.9
|
—
|
—
|
Adverse Events
ASP8062
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ASP8062 in Combination With Morphine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo in Combination With Morphine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ASP8062
n=16 participants at risk
Participants received ASP8062 tablet, orally once daily on days 1 through 9.
|
ASP8062 in Combination With Morphine
n=15 participants at risk
Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
|
Placebo
n=8 participants at risk
Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
Placebo in Combination With Morphine
n=8 participants at risk
Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Eye disorders
Vision blurred
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
13.3%
2/15 • Number of events 2 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
40.0%
6/15 • Number of events 6 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
33.3%
5/15 • Number of events 5 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
25.0%
2/8 • Number of events 3 • From first dose of study drug up to end of study visit (up to day 25)
|
|
General disorders
Asthenia
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
General disorders
Feeling abnormal
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
General disorders
Feeling of relaxation
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
General disorders
Infusion site extravasation
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 2 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Infections and infestations
Furuncle
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Investigations
Lipase increased
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 3 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • From first dose of study drug up to end of study visit (up to day 25)
|
13.3%
2/15 • Number of events 3 • From first dose of study drug up to end of study visit (up to day 25)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to end of study visit (up to day 25)
|
37.5%
3/8 • Number of events 4 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Psychiatric disorders
Abnormal dreams
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Psychiatric disorders
Euphoric mood
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
33.3%
5/15 • Number of events 5 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
50.0%
4/8 • Number of events 4 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
6.7%
1/15 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
13.3%
2/15 • Number of events 2 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
20.0%
3/15 • Number of events 3 • From first dose of study drug up to end of study visit (up to day 25)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
|
Vascular disorders
Flushing
|
0.00%
0/16 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/15 • From first dose of study drug up to end of study visit (up to day 25)
|
0.00%
0/8 • From first dose of study drug up to end of study visit (up to day 25)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to end of study visit (up to day 25)
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER