Trial Outcomes & Findings for A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM) (NCT NCT02367066)
NCT ID: NCT02367066
Last Updated: 2016-06-23
Results Overview
MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve
COMPLETED
PHASE1
30 participants
Day -1 to Day 3 and Day 6 to Day 9
2016-06-23
Participant Flow
Male or female T2DM patients of non-childbearing potential aged \>=18 with 7.5\<=HbA1c\<=11%, 19\<BMI\<38 kg/m2, fasting plasma glucose in range 3-14 mmol/L and on Metformin as the only anti-diabetic treatment for the last 3 months
30 patients were enrolled in the study. 10 of these were screen failures, leaving 20 patients who started the started the study.
Participant milestones
| Measure |
AZD1981-Placebo
Sequence AZD1981-Placebo
|
Placebo-AZD1981
Sequence Placebo-AZD1981
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
Baseline characteristics by cohort
| Measure |
AZD1981-Placebo
n=10 Participants
Sequence AZD1981-Placebo
|
Placebo-AZD1981
n=10 Participants
Sequence Placebo-AZD1981
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.10 Years
STANDARD_DEVIATION 9.10 • n=93 Participants
|
54.80 Years
STANDARD_DEVIATION 6.80 • n=4 Participants
|
54.00 Years
STANDARD_DEVIATION 7.86 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Weight
|
87.28 kg
STANDARD_DEVIATION 18.95 • n=93 Participants
|
87.59 kg
STANDARD_DEVIATION 20.36 • n=4 Participants
|
87.44 kg
STANDARD_DEVIATION 19.14 • n=27 Participants
|
|
Height
|
166.80 cm
STANDARD_DEVIATION 10.70 • n=93 Participants
|
164.90 cm
STANDARD_DEVIATION 12.59 • n=4 Participants
|
165.80 cm
STANDARD_DEVIATION 11.41 • n=27 Participants
|
|
Body Mass Index
|
31.13 kg/m2
STANDARD_DEVIATION 3.58 • n=93 Participants
|
32.13 kg/m2
STANDARD_DEVIATION 5.37 • n=4 Participants
|
31.63 kg/m2
STANDARD_DEVIATION 4.47 • n=27 Participants
|
|
T2DM disease duration
|
10.30 Years
STANDARD_DEVIATION 4.24 • n=93 Participants
|
8.60 Years
STANDARD_DEVIATION 5.02 • n=4 Participants
|
9.50 Years
STANDARD_DEVIATION 4.61 • n=27 Participants
|
|
Current Metformin Daily Dose
|
1765.00 mg
STANDARD_DEVIATION 473.78 • n=93 Participants
|
1895.00 mg
STANDARD_DEVIATION 390.48 • n=4 Participants
|
1830.00 mg
STANDARD_DEVIATION 427.78 • n=27 Participants
|
|
HbA1c
|
9.50 %
STANDARD_DEVIATION 1.24 • n=93 Participants
|
9.30 %
STANDARD_DEVIATION 0.88 • n=4 Participants
|
9.40 %
STANDARD_DEVIATION 1.06 • n=27 Participants
|
PRIMARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose
|
0.92 h*nmol/L
Standard Deviation 1.14
|
0.98 h*nmol/L
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint MMTT C_max for Plasma Glucose
|
0.93 nmol/L
Standard Deviation 1.12
|
0.97 nmol/L
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
GGI=Glucose and GLP1 infusion AUC=Area Under Curve
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide
|
1.05 h*pmol/L
Standard Deviation 1.17
|
1.06 h*pmol/L
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin
|
0.99 h*mU/L
Standard Deviation 1.23
|
1.08 h*mU/L
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon
|
1.02 h*pmol/L
Standard Deviation 1.19
|
0.96 h*pmol/L
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide
|
1.01 h*pmol/L
Standard Deviation 1.15
|
1.09 h*pmol/L
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin
|
1.01 h*mU/L
Standard Deviation 1.19
|
1.07 h*mU/L
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin
|
1.03 h*mU/L
Standard Deviation 1.25
|
1.04 h*mU/L
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon
|
1.01 h*mmol/L
Standard Deviation 1.08
|
0.97 h*mmol/L
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon
|
1.01 h*mmol/L
Standard Deviation 1.06
|
0.99 h*mmol/L
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint Fasting Beta-cell Responsiveness
|
0.01 10^-9*(L/kg)*min
Standard Error 0.01
|
-0.00 10^-9*(L/kg)*min
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Day 3 and Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Fasting Insulin at Endpoint
|
11.70 UIU/ML
Standard Error 1.48
|
11.40 UIU/ML
Standard Error 1.48
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max
|
2507 nmol/L
Geometric Coefficient of Variation 71.09
|
3662 nmol/L
Geometric Coefficient of Variation 86.90
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Time of Maximum Plasma AZD1081 Concentration, t_ss,Max
|
2.00 h
Interval 1.0 to 4.0
|
1.00 h
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Plasma AZD1981 AUC(0-1h)
|
701.30 h*nmol/L
Geometric Coefficient of Variation 122.30
|
2061 h*nmol/L
Geometric Coefficient of Variation 74.66
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Plasma AZD1981 AUC(0-2h)
|
2071 h*nmol/L
Geometric Coefficient of Variation 97.56
|
5016 h*nmol/L
Geometric Coefficient of Variation 75.91
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min
|
202.40 nmol/L
Geometric Coefficient of Variation 39.12
|
376.20 nmol/L
Geometric Coefficient of Variation 83.28
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Plasma AZD1981 AUC(1-2h)
|
1344 h*nmol/L
Geometric Coefficient of Variation 88.76
|
2936 h*nmol/L
Geometric Coefficient of Variation 78.72
|
SECONDARY outcome
Timeframe: Days 3,9Population: One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Plasma Paracetamol Maximum Concentration, C_max
|
8074 ng/mL
Geometric Coefficient of Variation 37.32
|
7899 ng/mL
Geometric Coefficient of Variation 30.51
|
SECONDARY outcome
Timeframe: Days 3,9Population: One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Time of Maximum Plasma Paracetamol Concentration, t_max
|
3.50 h
Interval 0.5 to 4.0
|
3.50 h
Interval 1.0 to 4.02
|
SECONDARY outcome
Timeframe: Days 3,9Population: One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Plasma Paracetamol AUC(0-t)
|
19730 h*ng/ML
Geometric Coefficient of Variation 46.64
|
18850 h*ng/ML
Geometric Coefficient of Variation 26.38
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide
|
1.02 h*pmol/L
Standard Deviation 1.16
|
1.03 h*pmol/L
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Day -1 to Day 3 and Day 6 to Day 9Population: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose
|
0.96 h*mmol/L
Standard Deviation 1.09
|
0.97 h*mmol/L
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Plasma AZD1981 AUC(0-4h)
|
5793 h*nmol/L
Geometric Coefficient of Variation 53.96
|
NA h*nmol/L
Geometric Coefficient of Variation NA
PK not measured for this time interval
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Plasma AZD1981 AUC(0-12h)
|
12460 h*nmol/L
Geometric Coefficient of Variation 36.79
|
NA h*nmol/L
Geometric Coefficient of Variation NA
PK not measured for this time interval
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Plasma AZD1981 AUC(0-24h)
|
24930 h*nmol/L
Geometric Coefficient of Variation 36.79
|
NA h*nmol/L
Geometric Coefficient of Variation NA
PK not measured for this time interval
|
SECONDARY outcome
Timeframe: Days 2,3,8,9Population: One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.
Outcome measures
| Measure |
AZD1981
n=20 Participants
AZD1981, oral tablet
|
Placebo
n=20 Participants
Placebo, oral tablet
|
|---|---|---|
|
Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F
|
21.94 L/h
Standard Deviation 8.19
|
NA L/h
Standard Deviation NA
PK not measured for this time interval
|
Adverse Events
AZD1981
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD1981
n=20 participants at risk
AZD1981, oral tablet
|
Placebo
n=20 participants at risk
Placebo, oral tablet
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20
|
5.0%
1/20
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20
|
10.0%
2/20
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20
|
5.0%
1/20
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20
|
5.0%
1/20
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/20
|
5.0%
1/20
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
|
5.0%
1/20
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
5.0%
1/20
|
|
General disorders
Vessel puncture site haemorrhage
|
10.0%
2/20
|
10.0%
2/20
|
|
General disorders
Local swelling
|
0.00%
0/20
|
5.0%
1/20
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/20
|
5.0%
1/20
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/20
|
5.0%
1/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place