Trial Outcomes & Findings for Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis (NCT NCT00748410)
NCT ID: NCT00748410
Last Updated: 2020-10-30
Results Overview
Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Baseline (Day -1) and Day 1 and 7
Results posted on
2020-10-30
Participant Flow
A total of 3 participants were enrolled and randomized from 22 January 2009 to 12 December 2009. This study was conducted at Academic Medical Centre, Amsterdam, The Netherlands. The study was early terminated on 17 February 2010.
Participant milestones
| Measure |
SB656933 20 Milligram (mg)
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 milliliter(mL) of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
SB656933 20 mg
n=1 Participants
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
n=2 Participants
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 Years
STANDARD_DEVIATION 0.00 • n=5 Participants
|
39 Years
STANDARD_DEVIATION 15.56 • n=7 Participants
|
46 Years
STANDARD_DEVIATION 15.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 1 and 7Population: The 'All Subjects population' was defined as all participants who received at least one dose of study medication. Only those participants with data available at the specified time points were analyzed.
Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.
Outcome measures
| Measure |
SB656933 20 mg
n=1 Participants
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
n=2 Participants
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
|---|---|---|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99001, Descending colon, Day 1
|
—
|
1 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99001, Descending colon, Day 7
|
—
|
1 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99003, Sigmoid, Day 1
|
—
|
1 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99003, Sigmoid, Day 7
|
—
|
1 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99001, Sigmoid, Day 1
|
—
|
2 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99001, Sigmoid, Day 7
|
—
|
1 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99002, Rectum, Day 1
|
2 Score on scale
|
—
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99002, Rectum, Day 7
|
3 Score on scale
|
—
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99003, Rectum, Day 1
|
—
|
1 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99003, Rectum, Day 7
|
—
|
1 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99001, Rectum, Day 1
|
—
|
2 Score on scale
|
|
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
99001, Rectum, Day 7
|
—
|
1 Score on scale
|
SECONDARY outcome
Timeframe: Up to follow-up (7 to 10 days after last dose)Population: All subject population.
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
SB656933 20 mg
n=1 Participants
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
n=2 Participants
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 and 7Population: All subject population. Only those participants with data available at the specified time points were analyzed.
Vital sign measurements included SBP and DBP at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.
Outcome measures
| Measure |
SB656933 20 mg
n=1 Participants
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
n=2 Participants
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
|---|---|---|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99001, Day 1, pre-dose
|
—
|
90 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99001, Day 1, 1 hour
|
—
|
96 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99001, Day 1, 4 hour
|
—
|
98 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99001, Day 1, 8 hour
|
—
|
83 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99001, Day 7, pre-dose
|
—
|
78 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99001, Day 7, 1 hour
|
—
|
82 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99001, Day 7, 4 hour
|
—
|
89 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99001, Day 7, 8 hour
|
—
|
99 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99001, Day 1, pre-dose
|
—
|
135 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99001, Day 1, 1 hour
|
—
|
131 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99001, Day 1, 4 hour
|
—
|
138 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99001, Day 1, 8 hour
|
—
|
129 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99001, Day 7, pre-dose
|
—
|
113 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99001, Day 7, 1 hour
|
—
|
120 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99001, Day 7, 4 hour
|
—
|
133 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99001, Day 7, 8 hour
|
—
|
152 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99003, Day 1, pre-dose
|
—
|
69 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99003, Day 1, 1 hour
|
—
|
63 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99003, Day 1, 4 hour
|
—
|
77 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99003, Day 1, 8 hour
|
—
|
61 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99003, Day 7, pre-dose
|
—
|
55 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99003, Day 7, 1 hour
|
—
|
64 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99003, Day 7, 4 hour
|
—
|
61 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99003, Day 7, 8 hour
|
—
|
71 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99003, Day 1, pre-dose
|
—
|
108 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99003, Day 1, 1 hour
|
—
|
109 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99003, Day 1, 4 hour
|
—
|
122 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99003, Day 1, 8 hour
|
—
|
106 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99003, Day 7, pre-dose
|
—
|
108 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99003, Day 7, 1 hour
|
—
|
109 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99003, Day 7, 4 hour
|
—
|
110 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99003, Day 7, 8 hour
|
—
|
123 millimeter of mercury (mmHg)
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99002, Day 1, pre-dose
|
68 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99002, Day 1, 1 hour
|
63 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99002, Day 1, 4 hour
|
62 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99002, Day 1, 8 hour
|
81 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99002, Day 7, pre-dose
|
59 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99002, Day 7, 1 hour
|
64 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99002, Day 7, 4 hour
|
66 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DB: 99002, Day 7, 8 hour
|
72 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99002, Day 1, pre-dose
|
111 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99002, Day 1, 1 hour
|
118 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99002, Day 1, 4 hour
|
110 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99002, Day 1, 8 hour
|
119 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99002, Day 7, pre-dose
|
102 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99002, Day 7, 1 hour
|
99 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99002, Day 7, 4 hour
|
114 millimeter of mercury (mmHg)
|
—
|
|
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SB: 99002, Day 7, 8 hour
|
117 millimeter of mercury (mmHg)
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 7Population: All subjects population. Only those participants with data available at the specified time points were analyzed.
Vital sign measurements included heart rate at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.
Outcome measures
| Measure |
SB656933 20 mg
n=1 Participants
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
n=2 Participants
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
|---|---|---|
|
Vital Signs Assessment- Heart Rate
heart rate: 99001, Day 1, pre-dose
|
—
|
85 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99001, Day 1, 1 hour
|
—
|
80 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99001, Day 1, 4 hour
|
—
|
80 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99001, Day 1, 8 hour
|
—
|
77 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99001, Day 7, pre-dose
|
—
|
80 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99001, Day 7, 1 hour
|
—
|
77 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99001, Day 7, 4 hour
|
—
|
80 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99001, Day 7, 8 hour
|
—
|
87 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99003, Day 1, pre-dose
|
—
|
60 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99003, Day 1, 1 hour
|
—
|
62 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99003, Day 1, 4 hour
|
—
|
60 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99003, Day 1, 8 hour
|
—
|
71 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99003, Day 7, pre-dose
|
—
|
73 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99003, Day 7, 1 hour
|
—
|
74 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99003, Day 7, 4 hour
|
—
|
73 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99003, Day 7, 8 hour
|
—
|
73 beats per minute (bpm)
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99002, Day 1, pre-dose
|
58 beats per minute (bpm)
|
—
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99002, Day 1, 1 hour
|
62 beats per minute (bpm)
|
—
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99002, Day 1, 4 hour
|
64 beats per minute (bpm)
|
—
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99002, Day 1, 8 hour
|
73 beats per minute (bpm)
|
—
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99002, Day 7, pre-dose
|
68 beats per minute (bpm)
|
—
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99002, Day 7, 1 hour
|
72 beats per minute (bpm)
|
—
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99002, Day 7, 4 hour
|
67 beats per minute (bpm)
|
—
|
|
Vital Signs Assessment- Heart Rate
heart rate: 99002, Day 7, 8 hour
|
81 beats per minute (bpm)
|
—
|
SECONDARY outcome
Timeframe: Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7Population: All subjects population.
Stool sample was collected from 1-hour post dose until 8 hours post dose for faecal calprotectin measures. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.
Outcome measures
| Measure |
SB656933 20 mg
n=1 Participants
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
n=2 Participants
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
|---|---|---|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99002, Day1 pre-dose
|
350.86 milligram per litre (mg/L)
|
—
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99002, Day1 post dose (8 hour)
|
164.54 milligram per litre (mg/L)
|
—
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99002, Day 7 pre-dose
|
430.30 milligram per litre (mg/L)
|
—
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99002, Day 7 post dose (8 hour)
|
524.90 milligram per litre (mg/L)
|
—
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99003, Day1 pre-dose
|
—
|
314.21 milligram per litre (mg/L)
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99003, Day1 post dose (8 hour)
|
—
|
458.32 milligram per litre (mg/L)
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99003, Day 7 pre-dose
|
—
|
306.15 milligram per litre (mg/L)
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99001, Day1 pre-dose
|
—
|
85.43 milligram per litre (mg/L)
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99001, Day1 post dose (8 hour)
|
—
|
194.97 milligram per litre (mg/L)
|
|
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
99001, Day 7 pre-dose
|
—
|
134.04 milligram per litre (mg/L)
|
SECONDARY outcome
Timeframe: At 1, 2.25, 4, 8 hour on Day 1 and 7Population: All subjects population.
Blood samples were collected at 1, 2.25, 4, 8 hour on Day 1 and 7 for the analysis of amount of medicine in blood. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.
Outcome measures
| Measure |
SB656933 20 mg
n=1 Participants
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
n=2 Participants
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
|---|---|---|
|
Amount of Medicine in Blood
99002, Day 7, 2.25 hour
|
715.40 nanogram per hour (ng/hr)
|
—
|
|
Amount of Medicine in Blood
99001, Day 1, 1 hour
|
—
|
2831.20 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99001, Day 1, 2.25 hour
|
—
|
4293.70 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99001, Day 1, 4 hour
|
—
|
4107.40 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99001, Day 1, 8 hour
|
—
|
1234.80 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99001, Day 7, 1 hour
|
—
|
2893.90 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99001, Day 7, 2.25 hour
|
—
|
4238.70 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99001, Day 7, 4 hour
|
—
|
2722.40 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99001, Day 7, 8 hour
|
—
|
2005.00 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99003, Day 1, 1 hour
|
—
|
1076.80 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99003, Day 1, 2.25 hour
|
—
|
2606.90 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99003, Day 1, 4 hour
|
—
|
5192.70 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99003, Day 1, 8 hour
|
—
|
1288.50 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99003, Day 7, 1 hour
|
—
|
985.20 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99003, Day 7, 2.25 hour
|
—
|
1993.30 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99003, Day 7, 4 hour
|
—
|
3912.20 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99003, Day 7, 8 hour
|
—
|
1164.30 nanogram per hour (ng/hr)
|
|
Amount of Medicine in Blood
99002, Day 1, 1 hour
|
438.30 nanogram per hour (ng/hr)
|
—
|
|
Amount of Medicine in Blood
99002, Day 1, 2.25 hour
|
961.80 nanogram per hour (ng/hr)
|
—
|
|
Amount of Medicine in Blood
99002, Day 1, 4 hour
|
562.30 nanogram per hour (ng/hr)
|
—
|
|
Amount of Medicine in Blood
99002, Day 1, 8 hour
|
153.30 nanogram per hour (ng/hr)
|
—
|
|
Amount of Medicine in Blood
99002, Day 7, 1 hour
|
616.10 nanogram per hour (ng/hr)
|
—
|
|
Amount of Medicine in Blood
99002, Day 7, 4 hour
|
944.20 nanogram per hour (ng/hr)
|
—
|
|
Amount of Medicine in Blood
99002, Day 7, 8 hour
|
286.70 nanogram per hour (ng/hr)
|
—
|
Adverse Events
SB656933 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SB656933 100 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SB656933 20 mg
n=1 participants at risk
Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
SB656933 100 mg
n=2 participants at risk
Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Sensation of brick in stomach
|
0.00%
0/1 • Data for AE was collected up to follow-up (Visit 5) 7 to 10 days after last dose.
The 'All Subjects population' was defined as all participants who received at least one dose of study medication. This population was used for the reporting of AEs.
|
50.0%
1/2 • Data for AE was collected up to follow-up (Visit 5) 7 to 10 days after last dose.
The 'All Subjects population' was defined as all participants who received at least one dose of study medication. This population was used for the reporting of AEs.
|
|
Infections and infestations
herpes simplex
|
100.0%
1/1 • Data for AE was collected up to follow-up (Visit 5) 7 to 10 days after last dose.
The 'All Subjects population' was defined as all participants who received at least one dose of study medication. This population was used for the reporting of AEs.
|
0.00%
0/2 • Data for AE was collected up to follow-up (Visit 5) 7 to 10 days after last dose.
The 'All Subjects population' was defined as all participants who received at least one dose of study medication. This population was used for the reporting of AEs.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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