Trial Outcomes & Findings for A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition (NCT NCT04024501)
NCT ID: NCT04024501
Last Updated: 2021-03-18
Results Overview
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Day 1: Pre-dose and up to 72-hour Post-dose
Results posted on
2021-03-18
Participant Flow
All subjects signed and dated the informed consent form (ICF) before any study procedures were performed.
The study included a Screening Period of maximum 28 days.
Participant milestones
| Measure |
Overall-All Subjects
All subjects were randomized into 5-period, 5-treatment, crossover study to receive a single oral dose of 12 mg verinurad:
* Treatment 1: 1 x 12 mg verinurad ER8 capsule formulation, fasted.
* Treatment 2: 2 x 6 mg verinurad A-capsule formulation, fasted.
* Treatment 3: 2 x 6 mg verinurad A-capsule formulation, fed.
* Treatment 4: 2 x 6 mg verinurad B-capsule formulation, fasted.
* Treatment 5: 2 x 6 mg verinurad B-capsule formulation, fed.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition
Baseline characteristics by cohort
| Measure |
Overall-All Subjects
n=25 Participants
All subjects were randomized into 5-period, 5-treatment, crossover study to receive a single oral dose of 12 mg verinurad:
* Treatment 1: 1 x 12 mg verinurad ER8 capsule formulation, fasted.
* Treatment 2: 2 x 6 mg verinurad A-capsule formulation, fasted.
* Treatment 3: 2 x 6 mg verinurad A-capsule formulation, fed.
* Treatment 4: 2 x 6 mg verinurad B-capsule formulation, fasted.
* Treatment 5: 2 x 6 mg verinurad B-capsule formulation, fed.
|
|---|---|
|
Age, Continuous
|
38.1 Years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC)
|
171.3 ng*h/mL
Geometric Coefficient of Variation 47.60
|
167.5 ng*h/mL
Geometric Coefficient of Variation 33.72
|
87.14 ng*h/mL
Geometric Coefficient of Variation 65.84
|
149.0 ng*h/mL
Geometric Coefficient of Variation 39.78
|
150.2 ng*h/mL
Geometric Coefficient of Variation 42.57
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
AUC From Time 0 to the Last Quantifiable Concentration (AUC0-t) for the Analysis of PK Parameter
|
166.8 ng*h/mL
Geometric Coefficient of Variation 47.57
|
167.5 ng*h/mL
Geometric Coefficient of Variation 35.96
|
67.04 ng*h/mL
Geometric Coefficient of Variation 80.37
|
128.5 ng*h/mL
Geometric Coefficient of Variation 49.29
|
139.6 ng*h/mL
Geometric Coefficient of Variation 44.36
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter
|
25.51 ng/mL
Geometric Coefficient of Variation 53.66
|
31.88 ng/mL
Geometric Coefficient of Variation 62.41
|
8.243 ng/mL
Geometric Coefficient of Variation 81.12
|
23.39 ng/mL
Geometric Coefficient of Variation 66.08
|
17.02 ng/mL
Geometric Coefficient of Variation 54.00
|
SECONDARY outcome
Timeframe: Pre-dose and up to 24-hours Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
AUC From Time 0 to 24 Hours Post Dose (AUC0-24) for the Analysis of PK Parameter
|
132.6 ng*h/mL
Geometric Coefficient of Variation 48.40
|
138.5 ng*h/mL
Geometric Coefficient of Variation 39.67
|
54.85 ng*h/mL
Geometric Coefficient of Variation 80.02
|
102.9 ng*h/mL
Geometric Coefficient of Variation 54.45
|
110.6 ng*h/mL
Geometric Coefficient of Variation 47.83
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for the Analysis of PK Parameter
|
4.98 Hour
Interval 3.0 to 8.0
|
4.98 Hour
Interval 2.98 to 6.02
|
5.00 Hour
Interval 3.0 to 10.0
|
4.00 Hour
Interval 2.0 to 6.0
|
7.98 Hour
Interval 4.0 to 12.0
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) for the Analysis of PK Parameter
|
14.02 Hour
Standard Deviation 4.732
|
13.61 Hour
Standard Deviation 5.748
|
13.42 Hour
Standard Deviation 5.549
|
14.36 Hour
Standard Deviation 5.477
|
12.40 Hour
Standard Deviation 5.038
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for the Analysis of PK Parameter
|
77.86 Litre/hour
Standard Deviation 42.15
|
75.43 Litre/hour
Standard Deviation 25.71
|
160.5 Litre/hour
Standard Deviation 86.96
|
86.26 Litre/hour
Standard Deviation 32.22
|
87.10 Litre/hour
Standard Deviation 41.78
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRT) for the Analysis of PK Parameter
|
16.98 Hour
Standard Deviation 4.006
|
15.52 Hour
Standard Deviation 5.843
|
17.43 Hour
Standard Deviation 4.974
|
16.61 Hour
Standard Deviation 6.049
|
18.28 Hour
Standard Deviation 4.841
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Time of Last Quantifiable Plasma Concentration (Tlast) for the Analysis of PK Parameter
|
71.65 Hour
Interval 47.67 to 72.93
|
48.47 Hour
Interval 36.0 to 72.05
|
47.97 Hour
Interval 35.97 to 72.07
|
48.03 Hour
Interval 35.57 to 73.08
|
48.03 Hour
Interval 47.77 to 72.07
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Intravenous Dosing) (Vss/F) for the Analysis of PK Parameter
|
1275 Litre
Standard Deviation 612.8
|
1190 Litre
Standard Deviation 586.4
|
2756 Litre
Standard Deviation 1577
|
1472 Litre
Standard Deviation 855.9
|
1645 Litre
Standard Deviation 1157
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dosePopulation: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for the Analysis of PK Parameter
|
1529 Litre
Standard Deviation 953.1
|
1490 Litre
Standard Deviation 779.9
|
3120 Litre
Standard Deviation 2066
|
1810 Litre
Standard Deviation 1120
|
1719 Litre
Standard Deviation 1608
|
SECONDARY outcome
Timeframe: From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)Population: All subjects who received at least 1 dose of verinurad (any formulation) were included in the safety analysis for the study.
To assess AEs as variable of safety and tolerability of single doses of verinurad in healthy participants.
Outcome measures
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 Participants
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any treatment emergent adverse event (TEAE)
|
5 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Related TEAEs
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any serious TEAE (including death)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE leading to discontinuation of IMP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE leading to withdrawal from study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment 2: 2 x 6 mg A-capsule Fasted
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment 3: 2 x 6 mg A-capsule Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment 4: 2 x 6 mg B-capsule Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment 5: 2 x 6 mg B-capsule Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment 1: 1 x 12 mg ER8 Capsule Fasted
n=25 participants at risk
During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
|
Treatment 2: 2 x 6 mg A-capsule Fasted
n=25 participants at risk
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
|
Treatment 3: 2 x 6 mg A-capsule Fed
n=25 participants at risk
During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
|
Treatment 4: 2 x 6 mg B-capsule Fasted
n=25 participants at risk
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
|
Treatment 5: 2 x 6 mg B-capsule Fed
n=25 participants at risk
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
General disorders
Catheter site pain
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
General disorders
Catheter site related reaction
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 2 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
0.00%
0/25 • From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This confidential document is the property of AstraZeneca AB. No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB. Access to this document must be restricted to relevant parties.
- Publication restrictions are in place
Restriction type: OTHER