Trial Outcomes & Findings for GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects (NCT NCT03457727)
NCT ID: NCT03457727
Last Updated: 2021-05-19
Results Overview
Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Results posted on
2021-05-19
Participant Flow
This two-part study assessed the relative bioavailability of Danirixin (DNX) tablet formulations along with effect of food and gastric acid secretion suppression on DNX pharmacokinetics. This study was conducted at a single center in the United States from 07-Mar-2018 to 25-Jul-2018.
Danirixin hemihydrate salt tablet formulation manufactured using roller compaction (RC) was compared to test formulations manufactured by direct compression (DC) with an excipient hydroxypropyl methylcellulose (HPMC) to evaluate the most appropriate formulation/dosing regimen. A total of 40 participants were enrolled in the study.
Participant milestones
| Measure |
DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State
Participants received a sequence of the following: single oral dose of 50 milligrams (mg) DNX hydrobromide (HBr) hemihydrate tablet formulation (600 mg tablet manufactured by RC \[600 RC\]) on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (475 mg tablet manufactured by DC \[475 DC\]) on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (600 DC) on Day 1 of treatment period 3 and 50 mg DNX HBr hemihydrate 600 DC tablet formulation with containing 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fed state (with a high fat meal). The treatment periods were separated by a washout period of 5 days.
|
DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 600 RC on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC on Day 1 of treatment period 2, a single oral dose 50 mg DNX HBr hemihydrate 600 DC on Day 1 of treatment period 3 and a single oral dose of 50 mg DNX HBr hemihydrate 600 DC with 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fasted state. The treatment periods were separated by a washout period of 5 days.
|
DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC tablet formulation in fasted state on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with normal meal on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with high fat meal in treatment period 3, followed by a single oral dose of 50 mg DNX HBr monohydrate 475 DC with high fat meal in treatment period 4. The treatment periods were separated by a washout period of 5 days.
|
DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC in fasted state along with 40 mg omeprazole (OMP) during treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with normal meal in treatment period 2 and a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with high fat meal in treatment period 3. The treatment periods were separated by a washout period of 5 days. OMP was administered from Day -4 of each treatment period through washout periods.
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Reasons for withdrawal
| Measure |
DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State
Participants received a sequence of the following: single oral dose of 50 milligrams (mg) DNX hydrobromide (HBr) hemihydrate tablet formulation (600 mg tablet manufactured by RC \[600 RC\]) on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (475 mg tablet manufactured by DC \[475 DC\]) on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (600 DC) on Day 1 of treatment period 3 and 50 mg DNX HBr hemihydrate 600 DC tablet formulation with containing 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fed state (with a high fat meal). The treatment periods were separated by a washout period of 5 days.
|
DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 600 RC on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC on Day 1 of treatment period 2, a single oral dose 50 mg DNX HBr hemihydrate 600 DC on Day 1 of treatment period 3 and a single oral dose of 50 mg DNX HBr hemihydrate 600 DC with 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fasted state. The treatment periods were separated by a washout period of 5 days.
|
DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC tablet formulation in fasted state on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with normal meal on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with high fat meal in treatment period 3, followed by a single oral dose of 50 mg DNX HBr monohydrate 475 DC with high fat meal in treatment period 4. The treatment periods were separated by a washout period of 5 days.
|
DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC in fasted state along with 40 mg omeprazole (OMP) during treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with normal meal in treatment period 2 and a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with high fat meal in treatment period 3. The treatment periods were separated by a washout period of 5 days. OMP was administered from Day -4 of each treatment period through washout periods.
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|---|---|---|---|---|
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Part 2, Washout Period 1 (5 Days)
Adverse Event
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0
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0
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0
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1
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Baseline Characteristics
GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects
Baseline characteristics by cohort
| Measure |
DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State
n=8 Participants
Participants received a sequence of the following: single oral dose of 50 milligrams (mg) DNX hydrobromide (HBr) hemihydrate tablet formulation (600 mg tablet manufactured by RC \[600 RC\]) on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (475 mg tablet manufactured by DC \[475 DC\]) on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate tablet formulation (600 DC) on Day 1 of treatment period 3 and 50 mg DNX HBr hemihydrate 600 DC tablet formulation with containing 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fed state (with a high fat meal). The treatment periods were separated by a washout period of 5 days.
|
DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State
n=8 Participants
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 600 RC on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC on Day 1 of treatment period 2, a single oral dose 50 mg DNX HBr hemihydrate 600 DC on Day 1 of treatment period 3 and a single oral dose of 50 mg DNX HBr hemihydrate 600 DC with 5 percent HPMC on Day 1 of treatment period 4. All the formulations were administered in fasted state. The treatment periods were separated by a washout period of 5 days.
|
DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal
n=12 Participants
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC tablet formulation in fasted state on Day 1 of treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with normal meal on Day 1 of treatment period 2, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC along with high fat meal in treatment period 3, followed by a single oral dose of 50 mg DNX HBr monohydrate 475 DC with high fat meal in treatment period 4. The treatment periods were separated by a washout period of 5 days.
|
DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State
n=12 Participants
Participants received a sequence of the following: single oral dose of 50 mg DNX HBr hemihydrate 475 DC in fasted state along with 40 mg omeprazole (OMP) during treatment period 1, a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with normal meal in treatment period 2 and a single oral dose of 50 mg DNX HBr hemihydrate 475 DC and 40 mg OMP along with high fat meal in treatment period 3. The treatment periods were separated by a washout period of 5 days. OMP was administered from Day -4 of each treatment period through washout periods.
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Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|---|---|
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Age, Continuous
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69.4 Years
STANDARD_DEVIATION 3.54 • n=5 Participants
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70.9 Years
STANDARD_DEVIATION 4.58 • n=7 Participants
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71.3 Years
STANDARD_DEVIATION 4.14 • n=5 Participants
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69.4 Years
STANDARD_DEVIATION 2.68 • n=4 Participants
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70.3 Years
STANDARD_DEVIATION 3.70 • n=21 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=5 Participants
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6 Participants
n=7 Participants
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4 Participants
n=5 Participants
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8 Participants
n=4 Participants
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22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
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2 Participants
n=7 Participants
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8 Participants
n=5 Participants
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4 Participants
n=4 Participants
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18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
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1 Count of Participants
n=5 Participants
|
0 Count of Participants
n=7 Participants
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0 Count of Participants
n=5 Participants
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2 Count of Participants
n=4 Participants
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3 Count of Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Count of Participants
n=5 Participants
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8 Count of Participants
n=7 Participants
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12 Count of Participants
n=5 Participants
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10 Count of Participants
n=4 Participants
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37 Count of Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1Population: PK Population includes all participants for whom a PK sample was obtained and analyzed. Only those participants with data available at specified time frame were analyzed.
Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=5 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=6 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=6 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of Danirixin for Part 1
|
6166.7 Hours*nanograms per milliliter
Geometric Coefficient of Variation 19.20
|
6052.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 14.18
|
5816.4 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.99
|
5996.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.31
|
11394.6 Hours*nanograms per milliliter
Geometric Coefficient of Variation 30.07
|
11285.7 Hours*nanograms per milliliter
Geometric Coefficient of Variation 32.72
|
10957.4 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.55
|
11230.8 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.21
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1Population: PK population. Only those participants with data available at specified time frame were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Danirixin for Part 1
|
761.5 Nanograms/milliliter
Geometric Coefficient of Variation 27.22
|
712.8 Nanograms/milliliter
Geometric Coefficient of Variation 20.53
|
762.3 Nanograms/milliliter
Geometric Coefficient of Variation 37.23
|
659.2 Nanograms/milliliter
Geometric Coefficient of Variation 47.40
|
2708.2 Nanograms/milliliter
Geometric Coefficient of Variation 26.22
|
2418.5 Nanograms/milliliter
Geometric Coefficient of Variation 27.78
|
2607.1 Nanograms/milliliter
Geometric Coefficient of Variation 30.24
|
2511.8 Nanograms/milliliter
Geometric Coefficient of Variation 24.19
|
PRIMARY outcome
Timeframe: Up to 29 days in Part 1Population: Modified Intent-to-treat (mITT) Population includes all randomized participants
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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 or is medically significant.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) and Serious Adverse Events (SAEs) in Part 1
Any AE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Any Adverse Event (AE) and Serious Adverse Events (SAEs) in Part 1
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 29 days in Part 1Population: mITT Population
Vital signs included systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate were measured with participants in semi-supine position after 5 minutes rest.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Concern in Part 1
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 29 days in Part 1Population: mITT Population
Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 1 are presented.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern in Part 1
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 29 days in Part 1Population: mITT Population
Hematology parameters included platelet count, RBC Count, hemoglobin, hematocrit, MCV, MCH, %Reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Clinical chemistry parameters included potassium aspartate aminotransferase(AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct bilirubin, creatinine, sodium alanine, aminotransferase, (ALT)/ Serum Glutamic-Pyruvic, Transaminase (SGPT), total protein, fasting glucose, calcium, alkaline phosphatase and albumin. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Values of Potential Clinical Concern in Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of Danirixin for Part 1
|
5515.9 Hours*nanograms/milliliter
Geometric Coefficient of Variation 24.54
|
5573.6 Hours*nanograms/milliliter
Geometric Coefficient of Variation 17.65
|
5524.7 Hours*nanograms/milliliter
Geometric Coefficient of Variation 22.15
|
5287.0 Hours*nanograms/milliliter
Geometric Coefficient of Variation 28.27
|
11480.1 Hours*nanograms/milliliter
Geometric Coefficient of Variation 28.07
|
10977.2 Hours*nanograms/milliliter
Geometric Coefficient of Variation 30.52
|
10636.5 Hours*nanograms/milliliter
Geometric Coefficient of Variation 32.09
|
11015.8 Hours*nanograms/milliliter
Geometric Coefficient of Variation 28.35
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC [0-24]) of Danirixin for Part 1
|
4919.5 Hours*nanograms/milliliter
Geometric Coefficient of Variation 27.19
|
4952.0 Hours*nanograms/milliliter
Geometric Coefficient of Variation 18.25
|
4984.8 Hours*nanograms/milliliter
Geometric Coefficient of Variation 24.27
|
4705.2 Hours*nanograms/milliliter
Geometric Coefficient of Variation 27.96
|
10744.8 Hours*nanograms/milliliter
Geometric Coefficient of Variation 26.07
|
10419.9 Hours*nanograms/milliliter
Geometric Coefficient of Variation 27.78
|
10029.3 Hours*nanograms/milliliter
Geometric Coefficient of Variation 32.19
|
10319.9 Hours*nanograms/milliliter
Geometric Coefficient of Variation 26.14
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Time to Occurrence of Cmax (Tmax) of Danirixin for Part 1
|
3.897 Hours
Standard Deviation 0.9894
|
3.653 Hours
Standard Deviation 0.5089
|
3.585 Hours
Standard Deviation 1.2942
|
4.158 Hours
Standard Deviation 1.3556
|
1.165 Hours
Standard Deviation 0.3794
|
1.331 Hours
Standard Deviation 0.7536
|
1.214 Hours
Standard Deviation 0.2669
|
1.342 Hours
Standard Deviation 0.3768
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=5 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=6 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=6 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of Danirixin for Part 1
|
9.638 Hours
Geometric Coefficient of Variation 17.60
|
10.904 Hours
Geometric Coefficient of Variation 19.33
|
8.916 Hours
Geometric Coefficient of Variation 29.74
|
9.888 Hours
Geometric Coefficient of Variation 26.18
|
8.298 Hours
Geometric Coefficient of Variation 36.18
|
9.498 Hours
Geometric Coefficient of Variation 26.76
|
9.391 Hours
Geometric Coefficient of Variation 45.40
|
9.107 Hours
Geometric Coefficient of Variation 29.56
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of Danirixin for Part 1
|
47.660 Hours
Standard Deviation 0.2178
|
47.587 Hours
Standard Deviation 0.2200
|
44.657 Hours
Standard Deviation 8.3551
|
44.757 Hours
Standard Deviation 8.3813
|
44.372 Hours
Standard Deviation 8.9730
|
41.789 Hours
Standard Deviation 10.9667
|
41.699 Hours
Standard Deviation 10.9179
|
44.531 Hours
Standard Deviation 8.3335
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Danirixin for Part 1
|
0.323 Hours
Standard Deviation 0.3812
|
0.383 Hours
Standard Deviation 0.5917
|
0.383 Hours
Standard Deviation 0.5918
|
0.511 Hours
Standard Deviation 0.6661
|
0.000 Hours
Standard Deviation 0.000
|
0.065 Hours
Standard Deviation 0.1830
|
0.000 Hours
Standard Deviation 0.0000
|
0.000 Hours
Standard Deviation 0.0000
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=10 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=9 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=10 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of Danirixin for Part 2
|
12426.4 Hours*nanograms/milliliter
Geometric Coefficient of Variation 35.85
|
7761.2 Hours*nanograms/milliliter
Geometric Coefficient of Variation 41.31
|
8136.7 Hours*nanograms/milliliter
Geometric Coefficient of Variation 32.85
|
7356.4 Hours*nanograms/milliliter
Geometric Coefficient of Variation 34.65
|
14615.2 Hours*nanograms/milliliter
Geometric Coefficient of Variation 24.23
|
10185.0 Hours*nanograms/milliliter
Geometric Coefficient of Variation 34.57
|
8782.5 Hours*nanograms/milliliter
Geometric Coefficient of Variation 45.73
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of Danirixin for Part 2
|
12026.9 Hours*nanograms/milliliter
Geometric Coefficient of Variation 37.00
|
7484.2 Hours*nanograms/milliliter
Geometric Coefficient of Variation 39.37
|
7757.2 Hours*nanograms/milliliter
Geometric Coefficient of Variation 31.77
|
6986.9 Hours*nanograms/milliliter
Geometric Coefficient of Variation 32.54
|
12903.9 Hours*nanograms/milliliter
Geometric Coefficient of Variation 37.02
|
9023.8 Hours*nanograms/milliliter
Geometric Coefficient of Variation 42.46
|
7885.4 Hours*nanograms/milliliter
Geometric Coefficient of Variation 46.30
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=10 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=10 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=9 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of Danirixin for Part 2
|
11096.7 Hours*nanograms/milliliter
Geometric Coefficient of Variation 36.64
|
6482.2 Hours*nanograms/milliliter
Geometric Coefficient of Variation 37.93
|
6706.6 Hours*nanograms/milliliter
Geometric Coefficient of Variation 28.49
|
6187.1 Hours*nanograms/milliliter
Geometric Coefficient of Variation 30.41
|
12762.9 Hours*nanograms/milliliter
Geometric Coefficient of Variation 23.58
|
8681.0 Hours*nanograms/milliliter
Geometric Coefficient of Variation 32.68
|
7590.8 Hours*nanograms/milliliter
Geometric Coefficient of Variation 37.96
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Danirixin for Part 2
|
2317.4 Nanograms/milliliter
Geometric Coefficient of Variation 44.90
|
989.9 Nanograms/milliliter
Geometric Coefficient of Variation 47.91
|
969.9 Nanograms/milliliter
Geometric Coefficient of Variation 37.80
|
1019.8 Nanograms/milliliter
Geometric Coefficient of Variation 38.90
|
2292.5 Nanograms/milliliter
Geometric Coefficient of Variation 43.18
|
1389.7 Nanograms/milliliter
Geometric Coefficient of Variation 43.59
|
1132.5 Nanograms/milliliter
Geometric Coefficient of Variation 35.26
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Danirixin for Part 2
|
1.271 Hours
Geometric Coefficient of Variation 0.3374
|
3.749 Hours
Geometric Coefficient of Variation 0.6458
|
4.150 Hours
Geometric Coefficient of Variation 1.5008
|
3.355 Hours
Geometric Coefficient of Variation 1.3724
|
1.978 Hours
Geometric Coefficient of Variation 0.8770
|
2.887 Hours
Geometric Coefficient of Variation 0.7802
|
3.752 Hours
Geometric Coefficient of Variation 1.7384
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=10 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=9 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=10 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=7 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of Danirixin for Part 2
|
10.647 Hours
Geometric Coefficient of Variation 26.80
|
11.424 Hours
Geometric Coefficient of Variation 21.51
|
11.484 Hours
Geometric Coefficient of Variation 11.21
|
11.652 Hours
Geometric Coefficient of Variation 20.01
|
11.304 Hours
Geometric Coefficient of Variation 15.02
|
10.913 Hours
Geometric Coefficient of Variation 24.37
|
8.975 Hours
Geometric Coefficient of Variation 33.78
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of Danirixin for Part 2
|
45.139 Hours
Geometric Coefficient of Variation 6.6767
|
47.144 Hours
Geometric Coefficient of Variation 0.4440
|
47.200 Hours
Geometric Coefficient of Variation 0.4262
|
46.741 Hours
Geometric Coefficient of Variation 0.4843
|
45.217 Hours
Geometric Coefficient of Variation 7.0764
|
45.242 Hours
Geometric Coefficient of Variation 7.0723
|
40.869 Hours
Geometric Coefficient of Variation 10.8896
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2Population: PK population. Only those participants with data available at specified time points were analyzed
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Lag Time Before Observable Concentration (Tlag) of Danirixin for Part 2
|
0.000 Hours
Geometric Coefficient of Variation 0.0000
|
0.283 Hours
Geometric Coefficient of Variation 0.3554
|
0.641 Hours
Geometric Coefficient of Variation 0.4405
|
0.386 Hours
Geometric Coefficient of Variation 0.4922
|
0.000 Hours
Geometric Coefficient of Variation 0.0000
|
0.423 Hours
Geometric Coefficient of Variation 0.3097
|
0.370 Hours
Geometric Coefficient of Variation 0.6461
|
—
|
SECONDARY outcome
Timeframe: Up to 52 days in Part 2Population: mITT Population
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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 or is medically significant.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2
Any AE
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 52 days in Part 2Population: mITT Population
Vital signs included systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate were measured with participants in semi-supine position after 5 minutes rest.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Concern in Part 2
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 52 days in Part 2Population: mITT Population
Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 2 are presented.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern in Part 2
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 52 days in Part 2Population: mITT Population
Hematology parameters included platelet count, RBC Count, hemoglobin, hematocrit, MCV, MCH, %Reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Clinical chemistry parameters included potassium aspartate, Aminotransferase(AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct, bilirubin, creatinine sodium alanine, Aminotransferase, (ALT)/ Serum Glutamic-Pyruvic, Transaminase (SGPT), total protein, fasting glucose, calcium, alkaline phosphatase and albumin. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine.
Outcome measures
| Measure |
600RC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=11 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=12 Participants
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Values of Potential Clinical Concern in Part 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
Adverse Events
600RC High Fat
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
475DC High Fat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
600DC High Fat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
600DC 5%HPMC High Fat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
600RC Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
475DC Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
600DC Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
600DC 5%HPMC Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
475DC-Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
475DC-Normal Meal
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
475DC-High Fat
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
475DC-MONO High Fat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
475DC-Fasted OMP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
475DC-Normal Meal OMP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
475DC-High Fat OMP
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 |
600RC High Fat
n=8 participants at risk
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation along with a high fat meal
|
475DC High Fat
n=8 participants at risk
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation along with high fat meal
|
600DC High Fat
n=8 participants at risk
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation along with high fat meal
|
600DC 5%HPMC High Fat
n=8 participants at risk
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation along with high fat meal
|
600RC Fasted
n=8 participants at risk
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 RC tablet formulation under fasted condition
|
475DC Fasted
n=8 participants at risk
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation under fasted condition
|
600DC Fasted
n=8 participants at risk
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet formulation under fasted condition
|
600DC 5%HPMC Fasted
n=8 participants at risk
Participants received a single oral dose of DNX 50 mg HBr hemihydrate 600 DC tablet with 5 percent HPMC formulation under fasted condition
|
475DC-Fasted
n=12 participants at risk
Participants received a single dose of DNX 50 mg HBr hemihydrate 475 DC tablet formulation in fasted state
|
475DC-Normal Meal
n=12 participants at risk
Participants received DNX 50 mg HBr hemihydrate 475 DC formulation along with normal meal
|
475DC-High Fat
n=12 participants at risk
Participants received DNX 50 mg HBr hemihydrate 475 DC formulation along with high fat meal
|
475DC-MONO High Fat
n=12 participants at risk
Participants received DNX 50 mg HBr monohydrate 475 DC with 5 percent HPMC formulation along with high fat meal
|
475DC-Fasted OMP
n=11 participants at risk
Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP under fasted condition
|
475DC-Normal Meal OMP
n=11 participants at risk
Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP along with normal meal
|
475DC-High Fat OMP
n=12 participants at risk
Participants received DNX 50 mg HBr hemihydrate 475 DC formulation and OMP along with high fat meal
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Vessel puncture site haematoma
|
12.5%
1/8 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
12.5%
1/8 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
12.5%
1/8 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
16.7%
2/12 • Number of events 2 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
12.5%
1/8 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
12.5%
1/8 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
12.5%
1/8 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
12.5%
1/8 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
12.5%
1/8 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
8.3%
1/12 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
8.3%
1/12 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
8.3%
1/12 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
16.7%
2/12 • Number of events 2 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/8 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/12 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
0.00%
0/11 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
8.3%
1/12 • Number of events 1 • On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days
On-Treatment SAEs and nSAEs were reported for mITT Population.
|
Additional Information
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