Colitis, Ulcerative
Conditions
Keywords
CD11b, Ulcerative colitis, 99mTc-HMPAO-labelled leukocyte scintigraphy
Brief summary
This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis. 99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe the effect of SB656933 on the migration of PMN to inflamed tissue.
Interventions
DRUGSB-656933
7 days repeat dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* A history of ulcerative colitis for at least 3 months * moderately active UC, either stable on medications or in a flare of the disease * Mayo endoscopic score of 2 or 3 within 2 days of dosing. * Male or female between 18 and 65 years of age * Women of child bearing potential must use an effective method of contraception. * Male subjects must agree to use one of the specified contraception method, * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal at study start. * Signed written informed consent * QTcB or QTcF \< 450msec at screening
Exclusion criteria
* The subject has a positive pre-study drug/alcohol screen. * A positive test for HIV, hepatitis B or C. * History of regular alcohol consumption within 6 months of the study * Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication * Known allergies * recent participation in another trial * recent blood donation * Pregnant or lactating females * unwillingness or inability to follow study procedures * consumption of red wine, seville oranges, grapefruit or grapefruit juice in last 7 seven day before study start. * Mild UC, Mayo endoscopic score of 0 or 1. * Toxic megacolon or perforation on plain abdominal Xray. * Crohn's Disease, indeterminate colitis, bleeding disorders, or active ulcer disease. * Previous colonic surgery. * Current or recurrent disease, other than UC, that could affect the action, absorption or disposition of the study medication, or clinical or laboratory assessments. * Absolute neutrophil count below 2.0x109/L. * A positive culture for enteric pathogens that is clinically significant, presence of clostridium difficile toxin, or with ova and parasites detected by microscopy, or has a clinical suspicion of an infectious disease of the bowel. * Symptomatic GI stricture within 6 months of screening or obstructive symptoms within 3 months of screening. * Likely to require abdominal surgery within the study period. * Congenital or acquired immunodeficiency, including any immunologic diseases with gastrointestinal involvement except for UC. * Ongoing neoplastic disease of the bowel. * History of prostatitis, epididymitis, epididymal cysts, structural abnormalities or testicular cancer. * Subjects with abnormalities of the renal tract, renal stones or history of recurrent urinary tract infections (UTI.s). * Subjects with any history of autoimmune hepatitis or sclerosing cholangitis. Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden. * Blood pressure persistently ≥ 140/90 mmHg at screening * Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, pulmonary, hepatic, endocrine, metabolic, haematological, or neurological condition). * Clinically significant hepatic impairment(Evidence of cirrhosis, Clinical episodes of jaundice) * Current evidence of, or has been treated for a malignancy within the past 5 years. * BMI \<18 kg.m2 or \>35 kg/m2 * Clinically significant renal laboratory values. * Has not discontinued any prohibited concomitant medication prior to the screening visit or within the protocol-specified time period. * Has not remained on a stable dose of any permitted concomitant medication(s) for the protocol-specified time period preceding the Screening Visit. * history of substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline (Day -1) and Day 1 and 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to follow-up (7 to 10 days after last dose) | 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. |
| Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1 and 7 | 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. |
| Vital Signs Assessment- Heart Rate | Day 1 and 7 | 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. |
| Changes From Baseline to After Treatment in Faecal Calprotectin Levels | Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7 | 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. |
| Amount of Medicine in Blood | At 1, 2.25, 4, 8 hour on Day 1 and 7 | 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. |
Countries
Netherlands
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| SB656933 20 mg 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. | 1 |
| 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. | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Total | SB656933 20 mg | SB656933 100 mg |
|---|---|---|---|
| Age, Continuous | 46 Years STANDARD_DEVIATION 15.95 | 59 Years STANDARD_DEVIATION 0 | 39 Years STANDARD_DEVIATION 15.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 1 / 1 | 1 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
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)
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.
Time frame: Baseline (Day -1) and Day 1 and 7
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB656933 20 mg | 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 |
| SB656933 20 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
| SB656933 100 mg | 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 |
Secondary
Amount of Medicine in Blood
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.
Time frame: At 1, 2.25, 4, 8 hour on Day 1 and 7
Population: All subjects population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB656933 20 mg | Amount of Medicine in Blood | 99002, Day 1, 1 hour | 438.30 nanogram per hour (ng/hr) |
| SB656933 20 mg | Amount of Medicine in Blood | 99002, Day 1, 2.25 hour | 961.80 nanogram per hour (ng/hr) |
| SB656933 20 mg | Amount of Medicine in Blood | 99002, Day 1, 4 hour | 562.30 nanogram per hour (ng/hr) |
| SB656933 20 mg | Amount of Medicine in Blood | 99002, Day 1, 8 hour | 153.30 nanogram per hour (ng/hr) |
| SB656933 20 mg | Amount of Medicine in Blood | 99002, Day 7, 1 hour | 616.10 nanogram per hour (ng/hr) |
| SB656933 20 mg | Amount of Medicine in Blood | 99002, Day 7, 2.25 hour | 715.40 nanogram per hour (ng/hr) |
| SB656933 20 mg | Amount of Medicine in Blood | 99002, Day 7, 4 hour | 944.20 nanogram per hour (ng/hr) |
| SB656933 20 mg | Amount of Medicine in Blood | 99002, Day 7, 8 hour | 286.70 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99001, Day 7, 8 hour | 2005.00 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99003, Day 1, 1 hour | 1076.80 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99003, Day 1, 2.25 hour | 2606.90 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99003, Day 1, 4 hour | 5192.70 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99003, Day 1, 8 hour | 1288.50 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99003, Day 7, 2.25 hour | 1993.30 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99003, Day 7, 4 hour | 3912.20 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99003, Day 7, 8 hour | 1164.30 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99003, Day 7, 1 hour | 985.20 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99001, Day 1, 1 hour | 2831.20 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99001, Day 1, 2.25 hour | 4293.70 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99001, Day 1, 4 hour | 4107.40 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99001, Day 1, 8 hour | 1234.80 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99001, Day 7, 1 hour | 2893.90 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99001, Day 7, 2.25 hour | 4238.70 nanogram per hour (ng/hr) |
| SB656933 100 mg | Amount of Medicine in Blood | 99001, Day 7, 4 hour | 2722.40 nanogram per hour (ng/hr) |
Secondary
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
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.
Time frame: Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7
Population: All subjects population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB656933 20 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99002, Day1 pre-dose | 350.86 milligram per litre (mg/L) |
| SB656933 20 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99002, Day1 post dose (8 hour) | 164.54 milligram per litre (mg/L) |
| SB656933 20 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99002, Day 7 pre-dose | 430.30 milligram per litre (mg/L) |
| SB656933 20 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99002, Day 7 post dose (8 hour) | 524.90 milligram per litre (mg/L) |
| SB656933 100 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99003, Day1 pre-dose | 314.21 milligram per litre (mg/L) |
| SB656933 100 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99003, Day1 post dose (8 hour) | 458.32 milligram per litre (mg/L) |
| SB656933 100 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99003, Day 7 pre-dose | 306.15 milligram per litre (mg/L) |
| SB656933 100 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99001, Day1 pre-dose | 85.43 milligram per litre (mg/L) |
| SB656933 100 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99001, Day1 post dose (8 hour) | 194.97 milligram per litre (mg/L) |
| SB656933 100 mg | Changes From Baseline to After Treatment in Faecal Calprotectin Levels | 99001, Day 7 pre-dose | 134.04 milligram per litre (mg/L) |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Up to follow-up (7 to 10 days after last dose)
Population: All subject population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB656933 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 1 Participants |
| SB656933 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
| SB656933 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 1 Participants |
| SB656933 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
Secondary
Vital Signs Assessment- Heart Rate
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.
Time frame: Day 1 and 7
Population: All subjects population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB656933 20 mg | Vital Signs Assessment- Heart Rate | heart rate: 99002, Day 1, pre-dose | 58 beats per minute (bpm) |
| SB656933 20 mg | Vital Signs Assessment- Heart Rate | heart rate: 99002, Day 1, 1 hour | 62 beats per minute (bpm) |
| SB656933 20 mg | Vital Signs Assessment- Heart Rate | heart rate: 99002, Day 1, 4 hour | 64 beats per minute (bpm) |
| SB656933 20 mg | Vital Signs Assessment- Heart Rate | heart rate: 99002, Day 1, 8 hour | 73 beats per minute (bpm) |
| SB656933 20 mg | Vital Signs Assessment- Heart Rate | heart rate: 99002, Day 7, pre-dose | 68 beats per minute (bpm) |
| SB656933 20 mg | Vital Signs Assessment- Heart Rate | heart rate: 99002, Day 7, 1 hour | 72 beats per minute (bpm) |
| SB656933 20 mg | Vital Signs Assessment- Heart Rate | heart rate: 99002, Day 7, 4 hour | 67 beats per minute (bpm) |
| SB656933 20 mg | Vital Signs Assessment- Heart Rate | heart rate: 99002, Day 7, 8 hour | 81 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99003, Day 1, pre-dose | 60 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99003, Day 1, 1 hour | 62 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99003, Day 1, 4 hour | 60 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99003, Day 1, 8 hour | 71 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99001, Day 1, pre-dose | 85 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99003, Day 7, 1 hour | 74 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99003, Day 7, 4 hour | 73 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99003, Day 7, 8 hour | 73 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99003, Day 7, pre-dose | 73 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99001, Day 1, 1 hour | 80 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99001, Day 1, 4 hour | 80 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99001, Day 1, 8 hour | 77 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99001, Day 7, pre-dose | 80 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99001, Day 7, 1 hour | 77 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99001, Day 7, 4 hour | 80 beats per minute (bpm) |
| SB656933 100 mg | Vital Signs Assessment- Heart Rate | heart rate: 99001, Day 7, 8 hour | 87 beats per minute (bpm) |
Secondary
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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.
Time frame: Day 1 and 7
Population: All subject population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99002, Day 1, pre-dose | 68 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99002, Day 1, 1 hour | 63 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99002, Day 1, 4 hour | 62 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99002, Day 1, 8 hour | 81 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99002, Day 7, pre-dose | 59 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99002, Day 7, 1 hour | 64 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99002, Day 7, 4 hour | 66 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99002, Day 7, 8 hour | 72 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99002, Day 1, pre-dose | 111 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99002, Day 1, 1 hour | 118 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99002, Day 1, 4 hour | 110 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99002, Day 1, 8 hour | 119 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99002, Day 7, pre-dose | 102 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99002, Day 7, 1 hour | 99 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99002, Day 7, 4 hour | 114 millimeter of mercury (mmHg) |
| SB656933 20 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99002, Day 7, 8 hour | 117 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99003, Day 1, pre-dose | 69 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99003, Day 1, 1 hour | 63 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99003, Day 1, 4 hour | 77 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99003, Day 1, 8 hour | 61 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99003, Day 7, pre-dose | 55 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99003, Day 7, 1 hour | 64 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99003, Day 7, 4 hour | 61 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99003, Day 7, 8 hour | 71 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99003, Day 1, pre-dose | 108 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99003, Day 1, 1 hour | 109 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99003, Day 1, 4 hour | 122 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99003, Day 1, 8 hour | 106 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99003, Day 7, pre-dose | 108 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99003, Day 7, 1 hour | 109 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99001, Day 1, pre-dose | 90 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99003, Day 7, 8 hour | 123 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99003, Day 7, 4 hour | 110 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99001, Day 1, 1 hour | 96 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99001, Day 1, 4 hour | 98 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99001, Day 1, 8 hour | 83 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99001, Day 7, pre-dose | 78 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99001, Day 7, 1 hour | 82 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99001, Day 7, 4 hour | 89 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DB: 99001, Day 7, 8 hour | 99 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99001, Day 1, pre-dose | 135 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99001, Day 1, 1 hour | 131 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99001, Day 1, 4 hour | 138 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99001, Day 1, 8 hour | 129 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99001, Day 7, pre-dose | 113 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99001, Day 7, 1 hour | 120 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99001, Day 7, 4 hour | 133 millimeter of mercury (mmHg) |
| SB656933 100 mg | Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SB: 99001, Day 7, 8 hour | 152 millimeter of mercury (mmHg) |