A Phase 2 interventional study of GSK163090 1 mg and GSK163090 Placebo in Depressive Disorder, sponsored by GlaxoSmithKline. Completed at 15 sites in Russian Federation. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2018-03-19.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. Subjects will be given either the study drug or the matching placebo.
This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. Efficacy, safety and tolerability will be assessed in three treatment arms. The study will consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 9 weeks. Subjects who pass screening will be randomized on Day 1 to one of three treatment arms (low dose arm, high dose arm or placebo). Each treatment arm will contain approximately 50 subjects. The subject's depressive symptoms will be assessed using the HAMD17- CR.
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Exclusion Criteria:
Parallel Group - High Dose Arm, Low Dose Arm
Drug: GSK163090 1 mg · Drug: GSK163090 3 mg
Parallel Group
Drug: GSK163090 Placebo
Developed for the treatment of Major Depressive Disorder
Developed for the treatment of Major Depressive Disorder
Developed for the treatment of Major Depressive Disorder
Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 42
HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items were rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill). The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1 (pre-dose). Change from baseline in total Score was the difference between HAMD total score at the time point being analyzed to Day 1.
Time frame: Baseline (Day 1, pre-dose), Day 14 and Day 42
Change From Baseline in Bech Melancholia Subscale (BECH 6) Scale, on Day 14 and 42
The bech melancholia is sum of scores on 6 items- depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, somatic symptoms general (items 1, 2, 7, 8, 10 and 13 respectively). Each item having 5 responses. The items are rated on a scale of 0-4, where 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. Total possible score is 0-24. where the lowest possible score was 0, which represented an absence of depression and higher scores reflecting greater severity of diseases. Baseline was defined as the assessment done on Day 1. Change from baseline was the difference between BECH 6 scale at the time point being analyzed to randomization.
Time frame: Baseline (Day 1, pre-dose), Day 14 and Day 42
Change From Baseline in Quick Inventory of Depressive Symtomatology - Self Rated (QIDS-SR) Scale, on Day 14 and 42
The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle, and late insomnia or hypersomnia), appetite/weight increase/decrease and psychomotor agitation/retardation. A total score was obtained by summing scores on each domain. the scores ranges from 0 (none) to 27 (very severe), where the highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1. Change from Randomization in total score was the difference between QIDS total score at the time point being analyzed to randomization.
Time frame: Baseline (Day 1, pre-dose), Day 14 and Day 42
Number of Participants With Suicidal Behavior and Suicidal Ideation Subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS was a clinician-rated scale that evaluated severity and change of suicidality by integrating both behaviour and ideation. The 2 of 3 sections of the scale were suicidal behavior and suicidal ideation. For suicidal behaviour participants were scored as non-suicidal-0, preparatory acts or behavior communicating ideation-01, aborted attempt-2, interrupted attempt-3 or actual attempt-4. The score ranges from 0-4, where 0 was absence of suicidal behavior and 4 being the most severe form of suicidal behavior. On the Suicidal Ideation scale, participants were scored as non-suicidal-0, wish to be dead-1, non-specific active suicidal thoughts-2, active suicidal ideation with associated thoughts of methods without intent-3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan-4, active suicidal ideation with plan and intent-5. The score ranges from 0-5, where 0 was absence of suicidal ideation and 5 being the most severe form of suicidal ideation.
Time frame: Up to Day 52
Number of Participants With Abnormal Hematology Values of Clinical Concern Range (CCR).
Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) were: hemoglobin (Hb): \> 25, 180; hematocrit (Hct): \> 0.075, 0.54; absolute neutrophil count (ANC): \< 1.5, NA; platelet: \< 100, \> 550; white blood cells (WBC): \< 3,\> 20
Time frame: Up to Day 42
Number of Participants With Abnormal Chemistry Values of CCR
Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) were: albumin (unit: gram per liter): \< 30, NA; alanine aminotransferase (ALT): NA, \>= 3 times upper limit of normal; aspartate aminotransferase (AST): NA, \>= 3 times upper limit of normal; total bilirubin: NA, \>=1.5 times upper limit of normal; calcium: \< 2.0, \> 2.75; gamma glutamyl transferase (GGT): \< 3.0, \> 9; potassium: \< 3.0, \> 5.5; magnesium: \< 0.5, \> 1.23.
Time frame: Up to Day 42
Change From Baseline in Liver Chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGT
Clinical liver chemistry parameters of Alkaline Phosphatase , ALT, AST, GGT were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.
Time frame: Baseline (screening) up to Day 42
Change From Baseline in Liver Chemistry- Direct Bilirubin and Total Bilirubin
Liver chemistry parameters: Direct Bilirubin and Total Bilirubin were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.
Time frame: Baseline (screening) up to Day 42
Number of Participant of Urinanalysis Assessment Over Period
Urinalysis parameters included: Urine Occult Blood, Urine Ketones, Urine Ketones. data for number of participants with abnormal urinanalysis parameters was reported by dipstick method. dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. dipstick test gives results in a semi-quantitative manner, and results can be read as negative, Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Urine occult blood dipstick and urine general dipstick were semi quantitative results. Urine glucose and urine ketones dipstick results were in milimole per liter, urine protein dipstick results were in gram per liter.
Time frame: Screening (Day -10 to -2), Day 14 and Day 42
Change From Baseline in Electrocardiogram (ECG) Values -PR Interval, QRS Duration, QT Interval, QTcB, QTcF, RR Interval
Data for change from Baseline was reported for PR Interval, QRS Duration, QT Interval, QTcB, QTcF, and RR Interval. 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTcB ,QTcF, and RR intervals. Day -1 evening (PM) was the Baseline for participants with only Day -1 records. Day 1 PM Dose was the Baseline for participants with Day 1 records. Baseline was the mean of replicate assessments. Change from Baseline was the difference between the value at the time point analyzed and baseline value.
Time frame: Baseline (Day 1) and up to Day 42
Mean of Change From Baseline in Systolic and Diastolic Blood Pressure (BP)
Semi-supine systolic and diastolic blood pressure was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. BP was measured at least every hour until the values were within the normal range. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.
Time frame: Baseline (Day 1) , Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42
Mean of Change From Baseline in Heart Rate
Heart rate is the speed of the heartbeat measured by the number of contractions of the heart per minute, (beats per minute). Heart rate was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.
Time frame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42
Number of Participants With All Adverse Events (AEs), and Serious Adverse Events (SAEs)
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Time frame: Up to Day 52
Mean Last Observed Quantifiable Concentration (Ct) of GSK163090 Over the Period
Ctrough is defined as trough plasma concentration (measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]). Concentration was reported at specified time points.
Time frame: Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)
Area Under Concentration-time Curve (AUC) at Steady State
PK samples were supposed to be collected to estimate individual specific parameters like AUC however data for this outcome was not collected.
Time frame: Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)
Average Concentration (Cave) at Steady State
PK samples were supposed to be collected to estimate individual specific parameters like Cave however data for this outcome was not collected.
Time frame: Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)
Preliminary Pharmacokinetic/ Pharmacodynamic (PK/PD)Relationships for GSK163090 in Participants With MDD.
PK/PD relationships for GSK163090 in participants with MDD data was not collected.
Time frame: Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)
A total of 99 participants with major depressive disorder (MDD) were enrolled in this study. The study was conducted at sixteen centers in Russia from 23 April 2009 to 09 February 2010
| Milestone | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| Started | 31 | 36 | 32 |
| Completed | 25 | 25 | 24 |
| Not completed | 6 | 11 | 8 |
| Withdrew: Adverse event | 3 | 4 | 2 |
| Withdrew: Lack of efficacy | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 5 | 5 |
HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items were rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill). The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1 (pre-dose). Change from baseline in total Score was the difference between HAMD total score at the time point being analyzed to Day 1.
| Score on scale | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| DAY 14 | -10.9 ± 6.02 | -10.8 ± 5.68 | -10.3 ± 5.95 |
| DAY 42 | -18.6 ± 8.21 | -18.4 ± 6.54 | -16.7 ± 8.11 |
The bech melancholia is sum of scores on 6 items- depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, somatic symptoms general (items 1, 2, 7, 8, 10 and 13 respectively). Each item having 5 responses. The items are rated on a scale of 0-4, where 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. Total possible score is 0-24. where the lowest possible score was 0, which represented an absence of depression and higher scores reflecting greater severity of diseases. Baseline was defined as the assessment done on Day 1. Change from baseline was the difference between BECH 6 scale at the time point being analyzed to randomization.
| Score on scale | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| DAY 14 | -4.9 ± 3.14 | -4.6 ± 2.85 | -4.2 ± 3.33 |
| DAY 42 | -8.7 ± 4.19 | -8.4 ± 3.30 | -7.8 ± 4.36 |
The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle, and late insomnia or hypersomnia), appetite/weight increase/decrease and psychomotor agitation/retardation. A total score was obtained by summing scores on each domain. the scores ranges from 0 (none) to 27 (very severe), where the highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1. Change from Randomization in total score was the difference between QIDS total score at the time point being analyzed to randomization.
| Score on scale | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| Day 14 | -6.2 ± 3.40 | -6.1 ± 4.19 | -6.5 ± 3.96 |
| DAY 42 | -11.0 ± 4.75 | -11.4 ± 4.32 | -10.8 ± 4.57 |
The C-SSRS was a clinician-rated scale that evaluated severity and change of suicidality by integrating both behaviour and ideation. The 2 of 3 sections of the scale were suicidal behavior and suicidal ideation. For suicidal behaviour participants were scored as non-suicidal-0, preparatory acts or behavior communicating ideation-01, aborted attempt-2, interrupted attempt-3 or actual attempt-4. The score ranges from 0-4, where 0 was absence of suicidal behavior and 4 being the most severe form of suicidal behavior. On the Suicidal Ideation scale, participants were scored as non-suicidal-0, wish to be dead-1, non-specific active suicidal thoughts-2, active suicidal ideation with associated thoughts of methods without intent-3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan-4, active suicidal ideation with plan and intent-5. The score ranges from 0-5, where 0 was absence of suicidal ideation and 5 being the most severe form of suicidal ideation.
| Participants | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| suicidal behavior | 0 | 0 | 0 |
| suicidal ideation,Day1,Wish to be dead | 7 | 5 | 4 |
| suicidal ideation,Day14,Wish to be dead | 1 | 1 | 1 |
Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) were: hemoglobin (Hb): \> 25, 180; hematocrit (Hct): \> 0.075, 0.54; absolute neutrophil count (ANC): \< 1.5, NA; platelet: \< 100, \> 550; white blood cells (WBC): \< 3,\> 20
| Participants | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| Hb,screening, Low | 2 | 0 | 0 |
| Hb,Day 14, Low | 2 | 0 | 0 |
| Hct,screening, Low | 2 | 0 | 0 |
| ANC,screening, Low | 1 | 0 | 0 |
| ANC,Day14, Low | 1 | 1 | 1 |
| ANC,Day42, Low | 1 | 0 | 1 |
| Platelet,screening, High | 1 | 0 | 0 |
| Platelet,Day 14, High | 1 | 0 | 0 |
| Platelet,Day 42, High | 1 | 0 | 0 |
| WBC,Day 14, High | 0 | 2 | 0 |
| WBC,Day 14, Low | 1 | 1 | 1 |
| WBC,Day 42, Low | 1 | 0 | 1 |
Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) were: albumin (unit: gram per liter): \< 30, NA; alanine aminotransferase (ALT): NA, \>= 3 times upper limit of normal; aspartate aminotransferase (AST): NA, \>= 3 times upper limit of normal; total bilirubin: NA, \>=1.5 times upper limit of normal; calcium: \< 2.0, \> 2.75; gamma glutamyl transferase (GGT): \< 3.0, \> 9; potassium: \< 3.0, \> 5.5; magnesium: \< 0.5, \> 1.23.
| Participants | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| Albumin,screening, High | 0 | 1 | 1 |
| Albumin,Day 14, High | 1 | 1 | 0 |
| ALT,Day 14, High | 1 | 0 | 0 |
| ALT,Day 42, High | 0 | 1 | 0 |
| AST,Day 42, High | 0 | 1 | 0 |
| Total bilirubin,screening, High | 0 | 1 | 0 |
| Total bilirubin,Day 7, High | 0 | 1 | 0 |
| Calcium,Day14, Low | 1 | 0 | 1 |
| GGT,screening, High | 1 | 2 | 1 |
| GGT,Day14, High | 1 | 1 | 1 |
| GGT,Day42, High | 0 | 2 | 0 |
| Glucose,screening, High | 1 | 1 | 1 |
| Glucose,Day 14, High | 0 | 4 | 1 |
| Glucose,Day42, High | 0 | 2 | 1 |
| Potassium,Day 14, High | 0 | 0 | 1 |
| Magnesium,screening, High | 0 | 2 | 0 |
| Magnesium,Day 14, High | 1 | 0 | 1 |
| Magnesium,Day 42, High | 0 | 0 | 1 |
Clinical liver chemistry parameters of Alkaline Phosphatase , ALT, AST, GGT were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.
| International unit per litre (IU/L) | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| ALP,Day7 | 2.8 ± 21.57 | -6.6 ± 25.51 | -1.7 ± 21.77 |
| ALP,Day14 | 4.6 ± 32.99 | 2.5 ± 9.79 | -5.4 ± 26.57 |
| ALP,Day28 | -2.1 ± 14.92 | -0.8 ± 20.47 | 0.8 ± 13.12 |
| ALP,Day42 | -1.1 ± 12.57 | 8.7 ± 45.92 | 0.2 ± 14.37 |
| ALT,Day7 | -1.0 ± 14.85 | 0.0 ± 14.20 | -1.4 ± 3.86 |
| ALT,Day14 | 7.3 ± 35.81 | -1.9 ± 15.96 | -2.8 ± 5.93 |
| ALT,Day28 | -2.8 ± 5.97 | -2.9 ± 13.49 | 0.1 ± 11.43 |
| ALT,Day42 | -2.7 ± 10.88 | 34.0 ± 189.18 | -1.9 ± 6.68 |
| AST,Day7 | -1.3 ± 9.91 | -1.2 ± 7.07 | -1.7 ± 6.83 |
| AST,Day14 | 1.8 ± 15.66 | -2.8 ± 13.62 | -3.2 ± 7.96 |
| AST,Day28 | -1.6 ± 4.80 | -3.6 ± 12.45 | -1.6 ± 7.93 |
| AST,Day42 | -1.8 ± 5.35 | 31.6 ± 174.14 | -2.3 ± 7.54 |
| GGT,Day14 | 11.1 ± 52.04 | 1.7 ± 23.67 | -5.2 ± 18.93 |
| GGT,Day42 | -1.8 ± 16.22 | 12.7 ± 75.43 | -8.6 ± 18.22 |
Liver chemistry parameters: Direct Bilirubin and Total Bilirubin were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.
| UMOL/L | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| Direct bilirubin,Day 7 | 0.59 ± 1.745 | 0.13 ± 1.511 | 0.38 ± 1.142 |
| Direct bilirubin,Day 14 | 0.61 ± 1.490 | -0.14 ± 1.369 | 0.25 ± 0.845 |
| Direct bilirubin,Day 28 | 0.66 ± 1.270 | -0.44 ± 1.541 | 0.06 ± 1.227 |
| Direct bilirubin,Day 42 | 0.31 ± 1.508 | -0.08 ± 1.517 | 0.43 ± 0.716 |
| Total bilirubin,Day 7 | 1.36 ± 4.465 | 0.66 ± 3.536 | 1.05 ± 3.771 |
| Total bilirubin,Day 14 | 1.24 ± 4.040 | -0.33 ± 3.696 | 0.59 ± 2.211 |
| Total bilirubin,Day 28 | 1.81 ± 3.421 | -1.05 ± 4.218 | 0.33 ± 3.251 |
| Total bilirubin,Day 42 | 0.88 ± 4.056 | -0.30 ± 3.610 | 1.28 ± 2.704 |
Urinalysis parameters included: Urine Occult Blood, Urine Ketones, Urine Ketones. data for number of participants with abnormal urinanalysis parameters was reported by dipstick method. dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. dipstick test gives results in a semi-quantitative manner, and results can be read as negative, Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Urine occult blood dipstick and urine general dipstick were semi quantitative results. Urine glucose and urine ketones dipstick results were in milimole per liter, urine protein dipstick results were in gram per liter.
| Participants | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| screening ,urine Occult Blood,+ | 2 | 2 | 1 |
| screening ,urine Occult Blood,++ | 4 | 0 | 2 |
| screening ,urine Occult Blood,+++ | 1 | 3 | 0 |
| screening,urine General,positive | 10 | 17 | 9 |
| screening,urine ketones,(1) | 1 | 0 | 0 |
| screening,urine ketones,(4) | 0 | 1 | 0 |
| screening,urine protein,(0.1) | 1 | 2 | 5 |
| screening,urine protein,(0.2) | 2 | 6 | 3 |
| screening,urine protein, (0.3) | 0 | 2 | 2 |
| Day 14 ,urine Occult Blood,+ | 0 | 1 | 0 |
| Day 14 ,urine Occult Blood,++ | 2 | 0 | 1 |
| Day 14 ,urine Occult Blood,+++ | 1 | 0 | 0 |
| Day 14,urine General,positive | 8 | 13 | 3 |
| Day 14,urine protein,(0.1) | 3 | 1 | 1 |
| Day 14,urine protein,(0.2) | 0 | 5 | 0 |
| Day 14,urine protein, (0.3) | 1 | 1 | 0 |
| Day 14,urine protein,(0.5) | 1 | 1 | 0 |
| Day 42,urine occult Blood,+ | 1 | 2 | 1 |
| Day 42,urine occult Blood,++ | 1 | 2 | 0 |
| Day 42,urine general,positive | 3 | 9 | 5 |
| Day 42,urine protein,(0.1) | 1 | 5 | 1 |
| Day 42,urine protein,(0.2) | 1 | 0 | 1 |
| Day 42,urine protein,(0.3) | 0 | 1 | 2 |
| Day 42,urine protein,(0.5) | 0 | 1 | 0 |
Data for change from Baseline was reported for PR Interval, QRS Duration, QT Interval, QTcB, QTcF, and RR Interval. 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTcB ,QTcF, and RR intervals. Day -1 evening (PM) was the Baseline for participants with only Day -1 records. Day 1 PM Dose was the Baseline for participants with Day 1 records. Baseline was the mean of replicate assessments. Change from Baseline was the difference between the value at the time point analyzed and baseline value.
| milisecond (msec) | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| PR Interval, Day -1,PM | 149.9 ± 20.06 | 148.2 ± 11.91 | 158.7 ± 16.05 |
| PR Interval, Day 1PM dose,pre dose | 156.4 ± 22.70 | 159.2 ± 18.43 | 163.6 ± 30.35 |
| PR Interval, Day 2AM dose,pre dose | -2.4 ± 9.59 | -1.2 ± 10.36 | -1.2 ± 10.01 |
| PR Interval, Day 2AM dose,3 h | -4.1 ± 9.47 | -0.8 ± 11.12 | -3.4 ± 7.02 |
| PR Interval, Day 2AM dose,6 h | -3.3 ± 9.14 | -2.3 ± 11.71 | -2.5 ± 7.75 |
| PR Interval, Day 7AM dose,pre dose | -1.5 ± 12.93 | -2.6 ± 10.99 | -1.6 ± 9.68 |
| PR Interval, Day 7AM dose,3 h | -4.8 ± 11.71 | -1.0 ± 11.44 | -0.5 ± 8.58 |
| PR Interval, Day 7AM dose,6 h | -1.8 ± 13.56 | -3.6 ± 11.56 | -1.8 ± 9.94 |
| PR Interval, Day 14AM dose,pre dose | 0.6 ± 13.78 | -1.8 ± 9.96 | 1.7 ± 9.56 |
| PR Interval, Day 14AM dose,3 h | -3.9 ± 12.39 | -1.7 ± 11.09 | -1.4 ± 14.53 |
| PR Interval, Day 14AM dose,6 h | 0.7 ± 11.70 | -0.8 ± 10.86 | -2.2 ± 10.00 |
| PR Interval, Day 42AM dose,pre dose | 1.3 ± 12.85 | -3.9 ± 10.91 | -0.2 ± 12.22 |
| PR Interval, Day 42AM dose,3 h | -0.2 ± 14.52 | -2.9 ± 12.90 | -3.7 ± 12.85 |
| PR Interval, Day 42AM dose,6 h | 0.3 ± 13.24 | -1.7 ± 9.20 | -2.7 ± 13.19 |
| QRS Duration, Day -1,PM | 90.9 ± 6.90 | 86.6 ± 6.65 | 89.5 ± 5.81 |
| QRS Duration, Day 1PM dose,pre dose | 90.6 ± 8.65 | 91.4 ± 8.34 | 90.0 ± 7.40 |
| QRS Duration, Day 2AM dose,pre dose | -1.0 ± 6.64 | -0.6 ± 5.99 | -0.7 ± 5.59 |
| QRS Duration, Day 2AM dose,3 h | -0.6 ± 7.73 | -0.1 ± 6.42 | -0.1 ± 5.32 |
| QRS Duration, Day 2AM dose,6 h | -1.4 ± 6.82 | -0.5 ± 5.43 | -0.4 ± 5.51 |
| QRS Duration, Day 7AM dose,pre dose | -1.6 ± 6.83 | -0.1 ± 5.90 | -0.3 ± 6.00 |
| QRS Duration, Day 7AM dose,3 h | -1.3 ± 6.67 | -1.3 ± 6.13 | 0.6 ± 5.56 |
| QRS Duration, Day 7AM dose,6 h | -2.0 ± 6.23 | -1.0 ± 6.77 | 0.5 ± 7.08 |
| QRS Duration, Day 14AM dose,pre dose | -0.5 ± 6.90 | 0.2 ± 6.86 | 0.5 ± 6.40 |
| QRS Duration, Day 14AM dose,3 h | -0.4 ± 7.62 | -1.4 ± 6.32 | 1.4 ± 7.18 |
| QRS Duration, Day 14AM dose,6 h | -0.8 ± 7.31 | -0.3 ± 6.24 | 0.7 ± 7.57 |
| QRS Duration, Day 42AM dose,pre dose | -0.5 ± 8.67 | -0.4 ± 5.65 | -1.0 ± 6.75 |
| QRS Duration, Day 42AM dose,3 h | 0.0 ± 8.55 | -0.9 ± 5.50 | 0.3 ± 6.12 |
| QRS Duration, Day 42AM dose,6 h | 0.5 ± 8.56 | 0.6 ± 5.87 | 1.2 ± 6.63 |
| QT Interval, Day -1,PM | 390.4 ± 19.42 | 375.1 ± 31.50 | 377.3 ± 30.89 |
| QT Interval, Day 1PM dose,pre dose | 372.4 ± 22.92 | 382.2 ± 16.07 | 380.7 ± 24.77 |
| QT Interval, Day 2AM dose,pre dose | -2.0 ± 24.13 | -3.2 ± 26.99 | -2.6 ± 20.37 |
| QT Interval, Day 2AM dose,3 h | -7.7 ± 21.57 | -3.8 ± 28.15 | -7.0 ± 21.73 |
| QT Interval, Day 2AM dose,6 h | -4.7 ± 21.43 | -6.1 ± 27.41 | -7.5 ± 17.92 |
| QT Interval, Day 7AM dose,pre dose | 1.3 ± 21.92 | -2.8 ± 19.98 | -0.0 ± 22.90 |
| QT Interval, Day 7AM dose,3 h | -3.7 ± 23.26 | -2.7 ± 18.10 | -1.7 ± 21.36 |
| QT Interval, Day 7AM dose,6 h | -4.6 ± 20.57 | -6.0 ± 19.66 | -1.9 ± 21.24 |
| QT Interval, Day 14AM dose,pre dose | 5.9 ± 22.87 | 2.7 ± 14.97 | 0.3 ± 23.61 |
| QT Interval, Day 14AM dose,3 h | -1.6 ± 23.64 | -5.0 ± 20.32 | -3.0 ± 23.36 |
| QT Interval, Day 14AM dose,6 h | 0.2 ± 21.32 | -5.0 ± 19.46 | 0.3 ± 21.26 |
| QT Interval, Day 42AM dose,pre dose | 5.5 ± 25.30 | -1.6 ± 29.31 | 4.1 ± 23.30 |
| QT Interval, Day 42AM dose,3 h | -0.2 ± 22.81 | -2.4 ± 26.68 | -2.0 ± 24.82 |
| QT Interval, Day 42AM dose,6 h | 3.4 ± 24.63 | -2.6 ± 30.94 | -3.7 ± 23.97 |
| QTcB, Day -1,PM | 428.5 ± 14.64 | 422.6 ± 25.22 | 410.5 ± 17.28 |
| QTcB, Day 1PM dose,pre dose | 418.6 ± 21.11 | 417.5 ± 18.51 | 419.3 ± 19.28 |
| QTcB, Day 2AM dose,pre dose | -3.8 ± 13.48 | 1.6 ± 18.90 | -2.6 ± 14.77 |
| QTcB, Day 2AM dose,3 h | -7.7 ± 15.30 | -1.1 ± 17.44 | -0.9 ± 14.65 |
| QTcB, Day 2AM dose,6 h | -5.5 ± 16.93 | -1.6 ± 18.49 | -0.2 ± 13.68 |
| QTcB, Day 7AM dose,pre dose | -2.2 ± 17.77 | -3.9 ± 22.66 | 3.6 ± 13.96 |
| QTcB, Day 7AM dose,3 h | -6.4 ± 19.71 | -2.4 ± 20.53 | 1.9 ± 18.00 |
| QTcB, Day 7AM dose,6 h | -4.3 ± 16.62 | -2.9 ± 19.49 | 4.3 ± 16.82 |
| QTcF, Day -1,PM | 415.30 ± 12.440 | 405.66 ± 17.954 | 398.97 ± 20.232 |
| QTcF, Day 1PM dose,pre dose | 402.47 ± 18.503 | 405.24 ± 12.952 | 405.76 ± 14.431 |
| QTcF, Day 2AM dose,pre dose | -3.28 ± 15.070 | -0.05 ± 18.340 | -2.70 ± 13.592 |
| QTcF, Day 2AM dose,3 h | -7.78 ± 14.789 | -2.22 ± 18.127 | -3.10 ± 11.385 |
| QTcF, Day 2AM dose,6 h | -5.28 ± 15.945 | -3.29 ± 17.988 | -2.80 ± 8.543 |
| QTcF, Day 7AM dose,pre dose | -1.03 ± 15.456 | -3.59 ± 17.264 | 2.43 ± 10.501 |
| QTcF, Day 7AM dose,3 h | -5.47 ± 16.491 | -2.59 ± 14.017 | 0.70 ± 12.787 |
| QTcF, Day 7AM dose,6 h | -4.47 ± 14.499 | -4.08 ± 14.692 | 2.18 ± 12.292 |
| QTcF, Day 14AM dose,pre dose | -1.44 ± 16.241 | -0.26 ± 15.470 | 0.60 ± 12.221 |
| QTcF, Day 14AM dose,3 h | -2.15 ± 14.577 | -4.21 ± 14.874 | -0.70 ± 16.000 |
| QTcF, Day 14AM dose,6 h | -2.40 ± 14.801 | -3.72 ± 15.555 | 3.02 ± 12.372 |
| QTcF, Day 42AM dose,pre dose | -1.10 ± 14.014 | 0.28 ± 18.937 | 6.02 ± 11.852 |
| QTcF, Day 42AM dose,3 h | -4.24 ± 14.575 | -1.68 ± 15.447 | 1.76 ± 12.233 |
| QTcF, Day 42AM dose,6 h | -1.58 ± 15.354 | -0.32 ± 18.769 | 1.50 ± 16.181 |
| RR Interval, Day -1,PM | 833.92 ± 94.941 | 803.45 ± 179.989 | 848.28 ± 101.842 |
| RR Interval, Day 1PM dose,pre dose | 796.78 ± 100.400 | 844.79 ± 105.834 | 834.03 ± 146.780 |
| RR Interval, Day 2AM dose,pre dose | 8.52 ± 87.037 | -22.39 ± 110.999 | 1.77 ± 92.320 |
| RR Interval, Day 2AM dose,3 h | -0.62 ± 90.126 | -12.00 ± 115.655 | -26.77 ± 131.444 |
| RR Interval, Day 2AM dose,6 h | 2.50 ± 84.105 | -20.53 ± 117.183 | -31.09 ± 124.683 |
| RR Interval, Day 7AM dose,pre dose | 16.29 ± 105.628 | 5.20 ± 122.749 | -17.08 ± 127.229 |
| RR Interval, Day 7AM dose,3 h | 10.29 ± 115.521 | -0.40 ± 119.174 | -17.24 ± 128.785 |
| RR Interval, Day 7AM dose,6 h | -2.24 ± 97.793 | -14.65 ± 122.435 | -27.36 ± 125.990 |
| RR Interval, Day 14AM dose,pre dose | 52.74 ± 140.757 | 20.29 ± 106.077 | -4.41 ± 109.804 |
| RR Interval, Day 14AM dose,3 h | 3.28 ± 122.146 | -8.39 ± 116.181 | -17.71 ± 112.985 |
| RR Interval, Day 14AM dose,6 h | 17.25 ± 103.448 | -8.28 ± 120.157 | -18.59 ± 108.155 |
| RR Interval, Day 42AM dose,pre dose | 46.40 ± 126.076 | -13.44 ± 145.953 | -11.87 ± 125.389 |
| RR Interval, Day 42AM dose,3 h | 28.22 ± 111.532 | -6.81 ± 148.104 | -26.69 ± 127.058 |
| RR Interval, Day 42AM dose,6 h | 35.60 ± 124.148 | -17.57 ± 167.309 | -35.87 ± 132.117 |
Semi-supine systolic and diastolic blood pressure was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. BP was measured at least every hour until the values were within the normal range. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.
| Millimeters of mercury (mmHg) | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| Systolic BP, Day 1PM dose,pre dose | 120.6 ± 10.65 | 120.3 ± 9.31 | 120.9 ± 13.84 |
| Systolic BP, Day 1PM dose,2 h | -0.8 ± 3.55 | 0.1 ± 4.53 | 1.5 ± 8.16 |
| Systolic BP ,Day 2AM dose,pre dose | -0.8 ± 5.19 | 1.2 ± 5.98 | 1.0 ± 5.55 |
| Systolic BP ,Day 2AM dose,3 h | -0.1 ± 4.33 | 1.0 ± 5.51 | 1.1 ± 6.53 |
| Systolic BP ,Day 2AM dose,6 h | -1.2 ± 3.80 | 0.2 ± 4.34 | 2.1 ± 8.53 |
| Systolic BP ,Day 2PM dose,1 h | -0.5 ± 4.42 | 0.3 ± 4.80 | 0.4 ± 8.35 |
| Systolic BP ,Day 3AM dose,pre dose | -1.6 ± 9.23 | 0.4 ± 5.84 | -1.1 ± 6.01 |
| Systolic BP ,Day 3AM dose,3 h | -1.2 ± 6.98 | 0.5 ± 7.10 | -0.8 ± 5.32 |
| Systolic BP ,Day 4AM dose,pre dose | -0.1 ± 5.44 | -0.2 ± 5.19 | -0.2 ± 6.07 |
| Systolic BP ,Day 4AM dose,3 h | 0.5 ± 5.02 | 2.1 ± 7.07 | -0.3 ± 5.22 |
| Systolic BP ,Day 5AM dose,pre dose | -1.4 ± 5.97 | -0.7 ± 5.16 | 0.5 ± 6.72 |
| Systolic BP ,Day 5AM dose,3 h | -0.8 ± 4.43 | -0.8 ± 5.18 | -0.6 ± 4.97 |
| Systolic BP ,Day 6AM dose,pre dose | -2.9 ± 5.19 | -0.2 ± 6.01 | 0.6 ± 7.08 |
| Systolic BP ,Day 6AM dose,3 h | 0.2 ± 4.48 | 0.5 ± 5.72 | 1.7 ± 8.65 |
| Systolic BP ,Day 7AM dose,pre dose | -1.4 ± 6.98 | 0.8 ± 6.65 | 2.8 ± 8.24 |
| Systolic BP ,Day 7AM dose,3 h | -0.8 ± 6.39 | 0.1 ± 7.42 | 2.7 ± 5.70 |
| Systolic BP ,Day 7AM dose,6 h | 1.5 ± 5.77 | 0.2 ± 5.29 | 2.8 ± 6.97 |
| Systolic BP ,Day 7PM dose,1h | -0.2 ± 6.11 | -0.7 ± 7.78 | 2.1 ± 9.20 |
| Systolic BP ,Day 8AM dose,pre dose | -1.8 ± 5.18 | -0.3 ± 8.34 | 0.3 ± 6.96 |
| Systolic BP ,Day 8AM dose,3 h | -1.0 ± 6.02 | -0.6 ± 6.94 | 1.4 ± 7.25 |
| Systolic BP ,Day 14AM dose,pre dose | -3.0 ± 6.77 | 1.0 ± 5.71 | 0.3 ± 8.16 |
| Systolic BP ,Day 14AM dose,3 h | -0.8 ± 7.65 | 0.9 ± 7.82 | 1.6 ± 8.00 |
| Systolic BP ,Day 14AM dose,6 h | -1.1 ± 8.03 | 1.6 ± 8.10 | 1.3 ± 8.86 |
| Systolic BP ,Day 14PM dose,1h | -2.0 ± 6.98 | 0.3 ± 7.48 | 1.8 ± 9.86 |
| Systolic BP ,Day 21AM dose,pre dose | -1.8 ± 6.73 | 0.0 ± 6.99 | 0.5 ± 8.43 |
| Systolic BP ,Day 21AM dose,3 h | -2.1 ± 7.20 | 0.7 ± 7.34 | 1.5 ± 10.43 |
| Systolic BP ,Day 28AM dose,pre dose | -1.4 ± 7.36 | -1.6 ± 5.95 | 2.9 ± 7.59 |
| Systolic BP ,Day 28AM dose,3 h | -1.2 ± 6.38 | 1.9 ± 6.23 | 3.2 ± 8.32 |
| Systolic BP ,Day 42AM dose,pre dose | 0.1 ± 6.71 | 1.1 ± 6.95 | 0.3 ± 7.71 |
| Systolic BP ,Day 42AM dose,3 h | -1.8 ± 6.32 | 2.7 ± 5.91 | 2.0 ± 9.17 |
| Diastolic BP, Day 1PM dose,pre dose | 76.2 ± 5.83 | 75.6 ± 5.95 | 76.8 ± 7.91 |
| Diastolic BP, Day 1PM dose,2 h | -0.4 ± 3.53 | 0.4 ± 3.30 | 0.7 ± 5.24 |
| Diastolic BP ,Day 2AM dose,pre dose | -0.7 ± 2.93 | -0.0 ± 3.65 | -0.2 ± 5.67 |
| Diastolic BP ,Day 2AM dose,3 h | -1.2 ± 2.88 | 0.7 ± 4.85 | 0.1 ± 4.03 |
| Diastolic BP ,Day 2AM dose,6 h | -0.8 ± 4.56 | -0.3 ± 3.88 | 1.3 ± 5.51 |
| Diastolic BP ,Day 2PM dose,1 h | 0.1 ± 3.83 | -0.0 ± 4.19 | -0.4 ± 6.45 |
| Diastolic BP ,Day 3AM dose,pre dose | -2.5 ± 4.41 | -0.1 ± 4.41 | -0.9 ± 6.53 |
| Diastolic BP ,Day 3AM dose,3 h | -2.3 ± 4.68 | 0.3 ± 4.87 | -0.4 ± 5.68 |
| Diastolic BP ,Day 4AM dose,pre dose | -1.9 ± 4.93 | 0.2 ± 4.35 | -0.7 ± 4.56 |
| Diastolic Systolic BP ,Day 4AM dose,3 h | -2.6 ± 5.15 | 0.0 ± 6.50 | -1.4 ± 4.85 |
| Diastolic BP ,Day 5AM dose,pre dose | -1.9 ± 4.94 | 0.4 ± 4.17 | -1.9 ± 5.42 |
| Diastolic BP ,Day 5AM dose,3 h | -1.2 ± 3.99 | -0.2 ± 4.04 | -1.7 ± 4.88 |
| Diastolic BP ,Day 6AM dose,pre dose | -1.3 ± 4.68 | 0.2 ± 5.06 | -1.7 ± 6.45 |
| Diastolic BP ,Day 6AM dose,3 h | -1.8 ± 5.29 | -0.2 ± 5.01 | -1.2 ± 7.14 |
| Diastolic BP ,Day 7AM dose,pre dose | -2.1 ± 5.87 | 0.1 ± 7.66 | 0.3 ± 6.67 |
| Diastolic BP ,Day 7AM dose,3 h | -1.2 ± 5.56 | -0.1 ± 6.19 | -0.6 ± 5.56 |
| Diastolic BP ,Day 7AM dose,6 h | -1.0 ± 4.16 | -0.7 ± 4.27 | -0.6 ± 5.75 |
| Diastolic BP ,Day 7PM dose,1h | -1.5 ± 4.21 | -0.3 ± 5.17 | -0.9 ± 7.12 |
| Diastolic BP ,Day 8AM dose,pre dose | -1.7 ± 5.36 | -0.5 ± 6.81 | -1.9 ± 7.14 |
| Diastolic BP ,Day 8AM dose,3 h | -1.7 ± 5.62 | -0.6 ± 6.18 | -0.7 ± 7.83 |
| Diastolic BP ,Day 14AM dose,pre dose | -2.7 ± 5.34 | -1.0 ± 5.57 | -0.2 ± 7.61 |
| Diastolic BP ,Day 14AM dose,3 h | -2.2 ± 5.11 | 0.0 ± 6.84 | -0.6 ± 7.21 |
| Diastolic BP ,Day 14AM dose,6 h | -2.8 ± 5.60 | 0.1 ± 6.54 | -0.8 ± 6.39 |
| Diastolic BP ,Day 14PM dose,1h | -2.8 ± 5.14 | -0.3 ± 5.03 | -0.9 ± 6.69 |
| Diastolic BP ,Day 21AM dose,pre dose | -2.9 ± 5.10 | 0.5 ± 5.38 | -0.8 ± 7.63 |
| Diastolic BP ,Day 21AM dose,3 h | -2.7 ± 5.35 | -0.8 ± 5.82 | -1.7 ± 7.43 |
| Diastolic BP ,Day 28AM dose,pre dose | -2.0 ± 5.12 | -0.9 ± 4.44 | 0.1 ± 6.72 |
| Diastolic BP ,Day 28AM dose,3 h | -2.1 ± 5.09 | 1.4 ± 4.50 | -1.4 ± 6.40 |
| Diastolic BP ,Day 42AM dose,pre dose | 0.4 ± 7.37 | 0.7 ± 5.25 | -0.2 ± 7.57 |
| Diastolic BP ,Day 42AM dose,3 h | -1.7 ± 7.39 | 2.5 ± 4.70 | -0.6 ± 7.66 |
Heart rate is the speed of the heartbeat measured by the number of contractions of the heart per minute, (beats per minute). Heart rate was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.
| Beats per minute | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| Heart rate, Day 1PM dose,pre dose | 73.0 ± 7.54 | 73.3 ± 10.67 | 71.8 ± 7.43 |
| Heart rate, Day 1PM dose,2 h | 1.4 ± 6.83 | 1.0 ± 4.63 | 1.1 ± 5.12 |
| Heart rate,Day 2AM dose,pre dose | -0.8 ± 5.73 | 0.4 ± 8.27 | 1.3 ± 6.63 |
| Heart rate,Day 2AM dose,3 h | 0.8 ± 5.19 | 0.8 ± 7.99 | 2.5 ± 6.47 |
| Heart rate,Day 2AM dose,6 h | 0.2 ± 6.08 | 1.9 ± 7.27 | 2.8 ± 6.56 |
| Heart rate,Day 2PM dose,1 h | 0.6 ± 7.02 | 1.0 ± 6.72 | 2.4 ± 7.28 |
| Heart rate,Day 3AM dose,pre dose | -0.7 ± 8.49 | 1.2 ± 6.49 | 1.3 ± 6.85 |
| Heart rate,Day 3AM dose,3 h | 0.1 ± 8.26 | 2.6 ± 6.70 | 2.0 ± 5.38 |
| Heart rate,Day 4AM dose,pre dose | -0.3 ± 10.04 | 0.7 ± 7.15 | 1.2 ± 5.03 |
| Heart rate,Day 4AM dose,3 h | 0.9 ± 8.23 | 1.7 ± 7.82 | 1.3 ± 5.65 |
| Heart rate,Day 5AM dose,pre dose | -0.4 ± 7.48 | -0.5 ± 6.48 | 1.0 ± 6.36 |
| Heart rate,Day 5AM dose,3 h | 0.1 ± 8.54 | 0.6 ± 6.09 | 1.7 ± 5.87 |
| Heart rate,Day 6AM dose,pre dose | 1.7 ± 10.54 | 0.2 ± 6.87 | 0.8 ± 5.43 |
| Heart rate,Day 6AM dose,3 h | 0.2 ± 9.42 | 0.4 ± 7.01 | -0.3 ± 7.60 |
| Heart rate,Day 7AM dose,pre dose | -0.8 ± 9.79 | -1.0 ± 6.95 | 2.4 ± 6.51 |
| Heart rate,Day 7AM dose,3 h | -0.7 ± 8.74 | -0.1 ± 6.94 | 2.1 ± 6.76 |
| Heart rate,Day 7AM dose,6 h | -1.3 ± 9.81 | -0.4 ± 7.67 | 3.0 ± 7.08 |
| Heart rate,Day 7PM dose,1h | -0.6 ± 9.83 | 0.2 ± 7.21 | 2.5 ± 6.64 |
| Heart rate BP ,Day 8AM dose,pre dose | -0.7 ± 8.38 | -0.4 ± 7.55 | 1.5 ± 5.98 |
| Heart rate,Day 8AM dose,3 h | -0.7 ± 8.55 | 0.2 ± 6.31 | 1.7 ± 5.60 |
| Heart rate,Day 14AM dose,pre dose | -2.1 ± 11.59 | 0.3 ± 6.37 | -0.5 ± 6.09 |
| Heart rate,Day 14AM dose,3 h | 1.2 ± 10.56 | 2.5 ± 6.26 | 0.6 ± 5.51 |
| Heart rate,Day 14AM dose,6 h | 1.6 ± 11.28 | 2.3 ± 6.60 | 0.7 ± 6.13 |
| Heart rate,Day 14PM dose,1h | -0.8 ± 9.40 | 0.6 ± 6.36 | 0.4 ± 5.49 |
| Heart rate,Day 21AM dose,pre dose | -0.3 ± 9.36 | -0.3 ± 7.70 | 2.4 ± 6.54 |
| Heart rate,Day 21AM dose,3 h | -0.5 ± 9.17 | 1.2 ± 6.99 | 2.1 ± 6.57 |
| Heart rate,Day 28AM dose,pre dose | -1.6 ± 8.44 | -0.8 ± 7.64 | 1.3 ± 5.97 |
| Heart rate,Day 28AM dose,3 h | -0.7 ± 8.92 | -0.3 ± 6.28 | 2.4 ± 6.28 |
| Heart rate,Day 42AM dose,pre dose | -2.4 ± 11.05 | -0.8 ± 7.13 | 1.1 ± 5.89 |
| Heart rate,Day 42AM dose,3 h | -1.4 ± 9.69 | -0.6 ± 8.33 | 1.3 ± 7.38 |
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
| Participants | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| Any AE | 17 | 24 | 14 |
| Any SAE | 0 | 0 | 0 |
Ctrough is defined as trough plasma concentration (measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]). Concentration was reported at specified time points.
| microgram per liter | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|
| Mean Last Observed Quantifiable Concentration (Ct) of GSK163090 Over the Period | 0.951 ± 0.6987 | 3.239 ± 2.1849 |
PK samples were supposed to be collected to estimate individual specific parameters like AUC however data for this outcome was not collected.
No measurements were reported for this outcome.
PK samples were supposed to be collected to estimate individual specific parameters like Cave however data for this outcome was not collected.
No measurements were reported for this outcome.
PK/PD relationships for GSK163090 in participants with MDD data was not collected.
No measurements were reported for this outcome.
Collected over Up to Day 52. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/31 (0%) | 0/31 (0%) | 17/31 (54.8%) |
| GSK163090 1 mg | 0/36 (0%) | 0/36 (0%) | 24/36 (66.7%) |
| GSK163090 3 mg | 0/32 (0%) | 0/32 (0%) | 14/32 (43.8%) |
| Event | Placebo | GSK163090 1 mg | GSK163090 3 mg |
|---|---|---|---|
| NauseaGastrointestinal disorders | 7/31 | 4/36 | 1/32 |
| HeadacheNervous system disorders | 4/31 | 5/36 | 4/32 |
| AnxietyPsychiatric disorders | 2/31 | 1/36 | 4/32 |
| DizzinessNervous system disorders | 2/31 | 4/36 | 2/32 |
| TinnitusEar and labyrinth disorders | 0/31 | 4/36 | 1/32 |
| InsomniaPsychiatric disorders | 1/31 | 3/36 | 3/32 |
| SomnolenceNervous system disorders | 1/31 | 3/36 | 0/32 |
| Alanine aminotransferase increasedInvestigations | 2/31 | 3/36 | 0/32 |
| AkathisiaNervous system disorders | 0/31 | 2/36 | 0/32 |
| Dry mouthGastrointestinal disorders | 0/31 | 2/36 | 1/32 |
| Age, Continuous(Years) | Placebo | GSK163090 1 mg | GSK163090 3 mg | Total |
|---|---|---|---|---|
| Mean | 40.7 ± 11.12 | 42.2 ± 14.57 | 47.3 ± 10.84 | 43.4 ± 12.60 |
| Sex: Female, Male(Participants) | Placebo | GSK163090 1 mg | GSK163090 3 mg | Total |
|---|---|---|---|---|
| Female | 20 | 21 | 21 | 62 |
| Male | 11 | 15 | 11 | 37 |
| Race (NIH/OMB)(Participants) | Placebo | GSK163090 1 mg | GSK163090 3 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 30 | 36 | 32 | 98 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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