Trial Outcomes & Findings for A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects (NCT NCT02496221)
NCT ID: NCT02496221
Last Updated: 2018-04-05
Results Overview
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Adjusted mean and its standard error are presented.
COMPLETED
PHASE4
20 participants
Day 4 in each treatment period
2018-04-05
Participant Flow
Eligible participants were randomized to one of the two treatments in Treatment Period 1 followed by a wash-out period and crossed over to other treatment in Treatment Period 2.
Participant milestones
| Measure |
Albiglutide 50 mg Followed by Placebo
Participants received Albiglutide 50 milligrams (mg) in Treatment Period 1 and Placebo in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
|
Placebo Followed by Albiglutide 50 mg
Participants received Placebo in Treatment Period 1 and Albiglutide 50 mg in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
|
|---|---|---|
|
Treatment Period 1 - 4 Days
STARTED
|
10
|
10
|
|
Treatment Period 1 - 4 Days
COMPLETED
|
10
|
10
|
|
Treatment Period 1 - 4 Days
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 - 4 Days
STARTED
|
10
|
10
|
|
Treatment Period 2 - 4 Days
COMPLETED
|
8
|
9
|
|
Treatment Period 2 - 4 Days
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Albiglutide 50 mg Followed by Placebo
Participants received Albiglutide 50 milligrams (mg) in Treatment Period 1 and Placebo in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
|
Placebo Followed by Albiglutide 50 mg
Participants received Placebo in Treatment Period 1 and Albiglutide 50 mg in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
|
|---|---|---|
|
Treatment Period 2 - 4 Days
Adverse Event
|
0
|
1
|
|
Treatment Period 2 - 4 Days
Protocol Violation
|
1
|
0
|
|
Treatment Period 2 - 4 Days
Physician Decision
|
1
|
0
|
Baseline Characteristics
A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Albiglutide 50 mg and Placebo
n=20 Participants
In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
|
|---|---|
|
Age, Continuous
|
35.8 Years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 4 in each treatment periodPopulation: Evaluable Subjects: Participants in the 'All Subjects' population who had gallbladder ultrasonography assessment pre-treatment and post-Baseline (during CCK infusion) for both periods. 'All Subjects' population comprised participants who received at least one dose of Investigational product.
Gallbladder ejection fraction (EF) is defined as the reduction in gallbladder volume at any time point from Baseline divided by baseline gallbladder volume and multiplied by 100. Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.
Outcome measures
| Measure |
Placebo
n=17 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=17 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect
|
47.4352 Percent of gallbladder EF
Standard Error 4.00997
|
38.4331 Percent of gallbladder EF
Standard Error 4.00997
|
—
|
PRIMARY outcome
Timeframe: Day 4 in each treatment periodPopulation: Evaluable Subjects
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.
Outcome measures
| Measure |
Placebo
n=17 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=17 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)
|
1004.2510 %*min
Standard Error 247.34751
|
458.2926 %*min
Standard Error 247.34751
|
—
|
PRIMARY outcome
Timeframe: Day 4 in each treatment periodPopulation: Evaluable Subjects
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion).
Outcome measures
| Measure |
Placebo
n=17 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=17 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion
|
37.64706 Minutes
Standard Deviation 13.1241
|
32.94118 Minutes
Standard Deviation 14.5836
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 4 in each treatment periodPopulation: Evaluable Subjects
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion).
Outcome measures
| Measure |
Placebo
n=17 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=17 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Maximum Gallbladder Ejection Fraction Value During CCK Infusion
|
44.5989 Percentage
Standard Error 5.11879
|
28.2997 Percentage
Standard Error 5.11879
|
—
|
PRIMARY outcome
Timeframe: Day 4 in each treatment periodPopulation: Evaluable Subjects
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error is presented.
Outcome measures
| Measure |
Placebo
n=17 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=17 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Area Under the Effect Curve for Gallbladder Volume (AUEC VL)
|
610.5642 mL*min
Standard Error 91.00301
|
863.1741 mL*min
Standard Error 91.00301
|
—
|
PRIMARY outcome
Timeframe: Day 4 in each treatment periodPopulation: Evaluable Subjects
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Adjusted mean and its standard error are presented.
Outcome measures
| Measure |
Placebo
n=17 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=17 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect
|
8.8385 Millilitre (mL)
Standard Error 1.39713
|
8.4637 Millilitre (mL)
Standard Error 1.39713
|
—
|
PRIMARY outcome
Timeframe: Day 4 in each treatment periodPopulation: Evaluable Subjects
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion).
Outcome measures
| Measure |
Placebo
n=17 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=17 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion
|
37.64706 Minutes
Standard Deviation 13.1241
|
32.94118 Minutes
Standard Deviation 14.5836
|
—
|
PRIMARY outcome
Timeframe: Day 4 in each treatment periodPopulation: Evaluable for Pancreatic: Participants with Baseline and post-Baseline pancreatic duct diameter values for both periods
Pancreatic duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error are presented. Baseline was calculated as the value at the indicated time point minus the Baseline value. Only those participants available at the indicated time points were analyzed.
Outcome measures
| Measure |
Placebo
n=6 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=5 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion
|
0.04359 Centimetre (CM)
Standard Error 0.01373
|
0.04511 Centimetre (CM)
Standard Error 0.01471
|
—
|
PRIMARY outcome
Timeframe: Day 4 in each treatment periodPopulation: Evaluable for Bile: Participants with Baseline and post-Baseline common bile duct diameter values for both periods
Common bile duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10, -5 min, followed by \[during CCK infusion\] every 5 min between 0 and 50 min, then \[after CCK infusion\] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error have been presented.
Outcome measures
| Measure |
Placebo
n=17 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=17 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion
|
0.08814 Centimetre (cm)
Standard Error 0.008308
|
0.07358 Centimetre (cm)
Standard Error 0.008308
|
—
|
SECONDARY outcome
Timeframe: Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (assessed up to a total of approximately 12 weeks)Population: All Subjects
Baseline is defined as Day 1 (pre-dose) visit. SBP and DBP were measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 1 (pre-dose), Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.
Outcome measures
| Measure |
Placebo
n=18 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=20 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Period 1, Day 2, n=10, 10
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 8.55
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 8.29
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Period 1, Day 3, n=10, 10
|
4.2 Millimeters of mercury (mmHg)
Standard Deviation 6.86
|
4.3 Millimeters of mercury (mmHg)
Standard Deviation 8.79
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Period 1, Day 4 (-15 min), n=10, 10
|
4.8 Millimeters of mercury (mmHg)
Standard Deviation 11.29
|
0.4 Millimeters of mercury (mmHg)
Standard Deviation 10.16
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Period 1, Day 4 (80 min), n=10, 10
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 8.53
|
9.4 Millimeters of mercury (mmHg)
Standard Deviation 7.23
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Period 2, Day 2, n=8, 10
|
2.1 Millimeters of mercury (mmHg)
Standard Deviation 9.70
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 9.48
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Period 2, Day 3, n=8, 10
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 7.67
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 8.63
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Period 2, Day 4 (-15 min), n=8, 10
|
4.5 Millimeters of mercury (mmHg)
Standard Deviation 9.15
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 6.01
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Period 2, Day 4 (80 min), n=8, 9
|
8.9 Millimeters of mercury (mmHg)
Standard Deviation 9.63
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 8.62
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Period 1, Day 2, n=10, 10
|
2.9 Millimeters of mercury (mmHg)
Standard Deviation 6.08
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 9.22
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Period 1, Day 3, n=10, 10
|
1.7 Millimeters of mercury (mmHg)
Standard Deviation 5.25
|
3.2 Millimeters of mercury (mmHg)
Standard Deviation 9.61
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Period 1, Day 4 (-15 min), n=10, 10
|
6.3 Millimeters of mercury (mmHg)
Standard Deviation 8.26
|
5.2 Millimeters of mercury (mmHg)
Standard Deviation 8.63
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Period 1, Day 4 (80 min), n=10, 10
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 5.12
|
9.5 Millimeters of mercury (mmHg)
Standard Deviation 6.65
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Period 2, Day 2, n=8, 10
|
-2.1 Millimeters of mercury (mmHg)
Standard Deviation 8.37
|
-4.3 Millimeters of mercury (mmHg)
Standard Deviation 7.12
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Period 2, Day 3, n=8, 10
|
-3.4 Millimeters of mercury (mmHg)
Standard Deviation 8.09
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation 10.15
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Period 2, Day 4 (-15 min), n=8, 10
|
3.3 Millimeters of mercury (mmHg)
Standard Deviation 5.23
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 7.07
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Period 2, Day 4 (80 min), n=8, 9
|
6.4 Millimeters of mercury (mmHg)
Standard Deviation 6.30
|
0.4 Millimeters of mercury (mmHg)
Standard Deviation 7.62
|
—
|
SECONDARY outcome
Timeframe: Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (a total of approximately 12 weeks)Population: All Subjects
Baseline is defined as Day 1 (pre-dose) visit. Heart rate was measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.
Outcome measures
| Measure |
Placebo
n=18 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=20 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Change From Baseline in Heart Rate
Period 1, Day 2, n=10, 10
|
2.4 Beats per minute (bpm)
Standard Deviation 2.67
|
4.3 Beats per minute (bpm)
Standard Deviation 4.60
|
—
|
|
Change From Baseline in Heart Rate
Period 1, Day 3, n=10, 10
|
4.7 Beats per minute (bpm)
Standard Deviation 6.72
|
7.9 Beats per minute (bpm)
Standard Deviation 4.41
|
—
|
|
Change From Baseline in Heart Rate
Period 1, Day 4 (-15 min), n=10, 10
|
3.8 Beats per minute (bpm)
Standard Deviation 9.15
|
8.5 Beats per minute (bpm)
Standard Deviation 4.74
|
—
|
|
Change From Baseline in Heart Rate
Period 1, Day 4 (80 min), n=10, 10
|
1.4 Beats per minute (bpm)
Standard Deviation 5.50
|
9.4 Beats per minute (bpm)
Standard Deviation 7.59
|
—
|
|
Change From Baseline in Heart Rate
Period 2, Day 2, n=8, 10
|
2.5 Beats per minute (bpm)
Standard Deviation 7.91
|
4.2 Beats per minute (bpm)
Standard Deviation 6.18
|
—
|
|
Change From Baseline in Heart Rate
Period 2, Day 3, n=8, 10
|
3.4 Beats per minute (bpm)
Standard Deviation 6.05
|
9.4 Beats per minute (bpm)
Standard Deviation 8.19
|
—
|
|
Change From Baseline in Heart Rate
Period 2, Day 4 (-15 min), n=8, 10
|
1.0 Beats per minute (bpm)
Standard Deviation 2.78
|
6.3 Beats per minute (bpm)
Standard Deviation 5.70
|
—
|
|
Change From Baseline in Heart Rate
Period 2, Day 4 (80 min), n=8, 9
|
1.8 Beats per minute (bpm)
Standard Deviation 3.58
|
6.3 Beats per minute (bpm)
Standard Deviation 11.48
|
—
|
SECONDARY outcome
Timeframe: Day -1 in each treatment period and Follow-up (at approximately Week 12)Population: All Subjects
The following parameters were measured through blood sampling. Hematology: Hematocrit, Hemoglobin, Lymphocytes, Neutrophil Count, Platelet Count, While Blood Cell Count (WBC); Clinical Chemistry: Albumin, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Potassium, Sodium, Total carbon dioxide; Liver Function Tests: Alanine transaminase (ALT), Aspartate transaminase, Alkaline Phosphatase, Total Bilirubin, Total Bilirubin + ALT. Values were considered to be of potential clinical importance if they had a 'low' or 'high' flag with respect to a pre-defined clinical concern range. Only participants starting each period (represented by n=X) with a particular treatment were analyzed. The follow-up time point is not restricted to a treatment or treatment period.
Outcome measures
| Measure |
Placebo
n=20 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance
Clinical Chemistry, Albiglutide Period 1, n=10
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance
Clinical Chemistry, Placebo Period 2, n=8
|
2 Participants
|
—
|
—
|
|
Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance
Clinical Chemistry, Follow-up, n=17
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance
Hematology, Albiglutide Period 1, n=10
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance
Hematology, Albiglutide Period 2, n=10
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 4 in each treatment period, and at Follow-up (at approximately Week 12)Population: All Subjects
Single 12-lead ECG was obtained in a semi-supine position after 5 minutes of rest at each indicated time point using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT, and QT corrected by Fridericia's formula (QTcF) intervals. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=18 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=20 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameters
QRS
|
-1.8 Milliseconds (msec)
Standard Deviation 6.82
|
-0.7 Milliseconds (msec)
Standard Deviation 4.46
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters
QT
|
-5.0 Milliseconds (msec)
Standard Deviation 17.69
|
-19.9 Milliseconds (msec)
Standard Deviation 21.08
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters
PR
|
2.1 Milliseconds (msec)
Standard Deviation 8.58
|
2.2 Milliseconds (msec)
Standard Deviation 5.76
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters
QTcF
|
-7.7 Milliseconds (msec)
Standard Deviation 12.33
|
-7.0 Milliseconds (msec)
Standard Deviation 15.85
|
—
|
SECONDARY outcome
Timeframe: From Day -1 in treatment period 1 and up to Follow-up Visit (a total of approximately 12 weeks)Population: All Subjects
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalised ratio \>1.5. AEs were classified as potentially drug-related, based on the investigator's judgement. Refer to the general AE/SAE module for a list of AEs and SAEs.
Outcome measures
| Measure |
Placebo
n=18 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=20 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
Any AE
|
8 Participants
|
9 Participants
|
—
|
|
Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
Any SAE
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
Any Drug-Related AE
|
5 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)Population: All Subjects
Urine dipstick test was carried out on Day -1 and at Follow-up. Urinalysis parameters assessed were glucose, ketones, nitrite and protein. Dipstick results were categorized as Normal (glucose), Negative or Trace (ketones), and Negative (nitrite and protein). Only participants available at the indicated time points (as represented by n=X, X, X in the category titles) were analyzed. The resultant fields with no available data have been represented by 'NA'.
Outcome measures
| Measure |
Placebo
n=18 Participants
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=20 Participants
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg and Placebo
n=20 Participants
Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
|
|---|---|---|---|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Glucose Normal; Day -1; n=18, 20, 0
|
18 Participants
|
20 Participants
|
NA Participants
The result fields with no available data have be represented by NA.
|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Glucose Normal; Follow-up; n=0, 0, 19
|
NA Participants
The result fields with no available data have be represented by NA.
|
NA Participants
The result fields with no available data have be represented by NA.
|
19 Participants
|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Ketones Negative; Day -1; n=18, 20, 0
|
18 Participants
|
19 Participants
|
NA Participants
The result fields with no available data have be represented by NA.
|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Ketones Trace; Day -1; n=18, 20, 0
|
0 Participants
|
1 Participants
|
NA Participants
The result fields with no available data have be represented by NA.
|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Ketones Negative; Follow-up; n=0, 0, 19
|
NA Participants
The result fields with no available data have be represented by NA.
|
NA Participants
The result fields with no available data have be represented by NA.
|
19 Participants
|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Nitrite Negative; Day -1; n=18, 20, 0
|
18 Participants
|
20 Participants
|
NA Participants
The result fields with no available data have be represented by NA.
|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Nitrite Negative; Follow-up; n=0, 0, 19
|
NA Participants
The result fields with no available data have be represented by NA.
|
NA Participants
The result fields with no available data have be represented by NA.
|
19 Participants
|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Protein Negative; Day -1; n=17, 20, 0
|
17 Participants
|
20 Participants
|
NA Participants
The result fields with no available data have be represented by NA.
|
|
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine Protein Negative; Follow-up; n=0, 0, 18
|
NA Participants
The result fields with no available data have be represented by NA.
|
NA Participants
The result fields with no available data have be represented by NA.
|
18 Participants
|
Adverse Events
Placebo
Albiglutide 50 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=18 participants at risk
In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
Albiglutide 50 mg
n=20 participants at risk
In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
3/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
5.6%
1/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
0.00%
0/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
5.6%
1/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
0.00%
0/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Nervous system disorders
Neck pain
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Nervous system disorders
Dizziness postural
|
5.6%
1/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
1/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
0.00%
0/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Gastrointestinal disorders
Abdominal painv
|
11.1%
2/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
0.00%
0/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
0.00%
0/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
General disorders
Fatigue
|
5.6%
1/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
General disorders
Feeling abnormal
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
5.6%
1/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
0.00%
0/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
|
Infections and infestations
Cystitis
|
0.00%
0/18 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
5.0%
1/20 • On-treament adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (a total of approximately 12 weeks)
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER