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This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD, Stage 3 | Experimental | Participants with Stage 3 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate [eGFR] 30 - 59 milliliters [mL]/minute) received a single 500 milligram (mg) oral dose of Vadadustat after fasting for at least 4 hours. |
|
| CKD, Stage 4 | Experimental | Participants with Stage 4 CKD (eGFR <30 mL/minute and not yet on dialysis) received a single 500 mg oral dose of Vadadustat after fasting for at least 4 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vadadustat | Drug | oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) was defined as any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study following study medication administration, regardless of causal relationship. This also included any clinically significant worsening or re-occurrence of a pre-existing condition, or AE occurring from an overdose of a study drug whether accidental or intentional or AE occurring from abuse of study drug or that has been associated with the discontinuation of the use of study drug. | Up to Day 8 |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Up to Day 8 |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. Number of participants with a clinically significant change from baseline in at least one of the assessed vital signs parameters is reported. | Up to Day 8 |
| Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance. | Up to Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Erythropoietin (EPO) | The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. | Baseline; 8, 12, and 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Change From Baseline in Hepcidin at 24 Hours | Baseline; 24 hours post-dose | |
| Exploratory: Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at 24 Hours | Baseline; 24 hours post-dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Akebia Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Saint Paul | Minnesota | 55114 | United States | ||
| Research Site |
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A total of 22 participants were enrolled in this study. The participants were placed in one of two cohorts, depending on disease state: Chronic Kidney Disease (CKD) Stage 3 (Cohort 1) or CKD Stage 4 (Cohort 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: CKD Stage 3 Vadadustat | Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 milliliter (mL)/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. |
| FG001 | Cohort 2: CKD Stage 4 Vadadustat | Participants with CKD Stage 4 with eGFR <30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled Population: The enrolled population consisted of all participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: CKD Stage 3 Vadadustat | Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 mL/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. |
| BG001 | Cohort 2: CKD Stage 4 Vadadustat |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) was defined as any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study following study medication administration, regardless of causal relationship. This also included any clinically significant worsening or re-occurrence of a pre-existing condition, or AE occurring from an overdose of a study drug whether accidental or intentional or AE occurring from abuse of study drug or that has been associated with the discontinuation of the use of study drug. | Intent-to-treat (ITT) population: all enrolled participants who received a dose of the study drug. | Posted | Count of Participants | Participants | Up to Day 8 |
|
Up to Day 8
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: CKD Stage 3 Vadadustat | Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 mL/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDra 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akebia Therapeutics | Akebia Therapeutics | 617-844-6128 | trials@akebia.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C000624313 | vadadustat |
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| Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval |
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). The baseline was defined as Day 1 pre-dose measurement. If missing, the last measurement prior to dosing was used. |
| Baseline; Day 2 |
| Change From Baseline in Heart Rate | The heart rate evaluation was performed after the participant had been resting comfortably in a supine position for approximately 10 minutes. | Baseline; Day 2 |
| Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings | A baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Up to Day 8 |
| Geometric Mean Maximum Observed Plasma Concentration (Cmax) of AKB-6548 | Plasma samples were collected from the participants at the defined time points. Cmax was defined as the maximum observed plasma concentration. Cmax was calculated using the standard non-compartmental method. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
| Median Time to Reach Cmax (Tmax) of AKB-6548 | Plasma samples were collected from the participants at the defined time points. Tmax was defined as the time to reach maximum plasma concentration. Tmax was calculated using the standard non-compartmental method. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
| Mean Terminal Elimination Rate Constant (λz) | Plasma samples were collected from the participants at the defined time points. λz was calculated using linear regression of the terminal linear portion of the log concentration vs. time curve. The parameter was calculated by linear least-squares regression analysis using three or more concentrations, excluding Cmax. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
| Median Terminal Elimination Half-life (T½) | Plasma samples were collected from the participants at the defined time points. T½ was defined as apparent terminal elimination half-life. T½ was calculated using the standard non-compartmental method. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
| Geometric Mean Area Under the Plasma Concentration-time Curve From 0 to Time T Over a Dosing Interval (AUC[0-T]) | Plasma samples were collected from the participants at the defined time points. AUC[0-T) was defined as the area under the plasma concentration-time curve, from time=0 to the last measurable concentration (Ct) up to 24 hours, calculated by the linear trapezoidal method. AUC[0-T) was calculated using the standard noncompartmental method.](streamdown:incomplete-link) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
| Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) | Plasma samples were collected from the participants at the defined time points. AUC[0-∞] was defined as the area under the plasma concentration-time curve from time=0 and extrapolated to infinity. AUC[0-∞] was calculated using the standard non-compartmental method. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
| Geometric Mean Apparent Oral Clearance (CL/F) | Plasma samples were collected from the participants at the defined time points. CL/F was defined as apparent oral clearance, calculated as Dose/AUC(0-inf). CL/F was calculated using the standard non-compartmental method. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
| Geometric Mean Apparent Volume of Distribution During the Terminal Phase (Vd/F) | Plasma samples were collected from the participants at the defined time points. Vd/F was defined as the apparent volume of distribution during the terminal phase, calculated as Dose/[λz * AUC(0-inf)]. Vd/F was calculated using the standard non-compartmental method. | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
| Exploratory: Change From Baseline in Transferrin at 24 Hours | Baseline; 24 hours post-dose |
| Exploratory: Change From Baseline in Cystatin-C at 24 Hours | Baseline; 24 hours post -dose |
| Exploratory: Change From Baseline in Adiponectin at 24 Hours | Baseline; 24 hours post -dose |
| Exploratory: Change From Baseline in Ferritin at 24 Hours | Baseline; 24 hours post-dose |
| Knoxville |
| Tennessee |
| 37920 |
| United States |
Participants with CKD Stage 4 with eGFR <30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Estimated Glomerular Filtration Rate | eGFR in normal range (60-89 milliliter/minute/1.73 meter square [mL/min/1.73m^2]) with other signs of kidney damage, like protein in urine or physical damage to the kidneys. eGFR 30-59, moderate kidney damage. eGFR 15-29, severe kidney damage. eGFR less than 15, the kidneys are close to failure or have already failed. | Mean | Standard Deviation | mL/min/1.73m^2 |
|
Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 mL/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition.
| OG001 | Cohort 2: CKD Stage 4 Vadadustat | Participants with CKD Stage 4 with eGFR <30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. |
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes. | ITT Population | Posted | Count of Participants | Participants | Up to Day 8 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. Number of participants with a clinically significant change from baseline in at least one of the assessed vital signs parameters is reported. | ITT Population | Posted | Count of Participants | Participants | Up to Day 8 |
|
|
|
| Primary | Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance. | ITT Population | Posted | Count of Participants | Participants | Up to Day 2 |
|
|
|
| Primary | Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). The baseline was defined as Day 1 pre-dose measurement. If missing, the last measurement prior to dosing was used. | ITT Population | Posted | Mean | Standard Deviation | Milliseconds | Baseline; Day 2 |
|
|
|
| Primary | Change From Baseline in Heart Rate | The heart rate evaluation was performed after the participant had been resting comfortably in a supine position for approximately 10 minutes. | ITT Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline; Day 2 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings | A baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes. | ITT Population | Posted | Count of Participants | Participants | Up to Day 8 |
|
|
|
| Primary | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of AKB-6548 | Plasma samples were collected from the participants at the defined time points. Cmax was defined as the maximum observed plasma concentration. Cmax was calculated using the standard non-compartmental method. | Pharmacokinetic (PK) Evaluable Population: all ITT participants who had adequate and reliable PK data for the evaluation of PK of AKB-6548 plasma concentrations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per millilitre (mcg/mL) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
|
|
|
| Primary | Median Time to Reach Cmax (Tmax) of AKB-6548 | Plasma samples were collected from the participants at the defined time points. Tmax was defined as the time to reach maximum plasma concentration. Tmax was calculated using the standard non-compartmental method. | PK Evaluable Population | Posted | Median | Full Range | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
|
|
|
| Primary | Mean Terminal Elimination Rate Constant (λz) | Plasma samples were collected from the participants at the defined time points. λz was calculated using linear regression of the terminal linear portion of the log concentration vs. time curve. The parameter was calculated by linear least-squares regression analysis using three or more concentrations, excluding Cmax. | PK Evaluable Population | Posted | Mean | Standard Deviation | 1/Hour | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
|
|
|
| Primary | Median Terminal Elimination Half-life (T½) | Plasma samples were collected from the participants at the defined time points. T½ was defined as apparent terminal elimination half-life. T½ was calculated using the standard non-compartmental method. | PK Evaluable Population | Posted | Median | Full Range | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
|
|
|
| Primary | Geometric Mean Area Under the Plasma Concentration-time Curve From 0 to Time T Over a Dosing Interval (AUC[0-T]) | Plasma samples were collected from the participants at the defined time points. AUC[0-T) was defined as the area under the plasma concentration-time curve, from time=0 to the last measurable concentration (Ct) up to 24 hours, calculated by the linear trapezoidal method. AUC[0-T) was calculated using the standard noncompartmental method.](streamdown:incomplete-link) | PK Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
|
|
|
| Primary | Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) | Plasma samples were collected from the participants at the defined time points. AUC[0-∞] was defined as the area under the plasma concentration-time curve from time=0 and extrapolated to infinity. AUC[0-∞] was calculated using the standard non-compartmental method. | PK Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
|
|
|
| Primary | Geometric Mean Apparent Oral Clearance (CL/F) | Plasma samples were collected from the participants at the defined time points. CL/F was defined as apparent oral clearance, calculated as Dose/AUC(0-inf). CL/F was calculated using the standard non-compartmental method. | PK Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Litre per Hour (L/hr) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
|
|
|
| Primary | Geometric Mean Apparent Volume of Distribution During the Terminal Phase (Vd/F) | Plasma samples were collected from the participants at the defined time points. Vd/F was defined as the apparent volume of distribution during the terminal phase, calculated as Dose/[λz * AUC(0-inf)]. Vd/F was calculated using the standard non-compartmental method. | PK Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) |
|
|
|
| Secondary | Change From Baseline in Mean Erythropoietin (EPO) | The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. | ITT Population. Overall number of participants analyzed represents participants with valid EPO measurements at both baseline and the post-dose hour. | Posted | Mean | Standard Deviation | milli-international units per milliliter | Baseline; 8, 12, and 24 hours post-dose |
|
|
|
| Other Pre-specified | Exploratory: Change From Baseline in Hepcidin at 24 Hours | Not Posted | Baseline; 24 hours post-dose | Participants |
| Other Pre-specified | Exploratory: Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at 24 Hours | Not Posted | Baseline; 24 hours post-dose | Participants |
| Other Pre-specified | Exploratory: Change From Baseline in Transferrin at 24 Hours | Not Posted | Baseline; 24 hours post-dose | Participants |
| Other Pre-specified | Exploratory: Change From Baseline in Cystatin-C at 24 Hours | Not Posted | Baseline; 24 hours post -dose | Participants |
| Other Pre-specified | Exploratory: Change From Baseline in Adiponectin at 24 Hours | Not Posted | Baseline; 24 hours post -dose | Participants |
| Other Pre-specified | Exploratory: Change From Baseline in Ferritin at 24 Hours | Not Posted | Baseline; 24 hours post-dose | Participants |
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Cohort 2: CKD Stage 4 Vadadustat | Participants with CKD Stage 4 with eGFR <30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. | 0 | 12 | 0 | 12 | 2 | 12 |
| Nausea | Gastrointestinal disorders | MedDra 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDra 11.0 | Systematic Assessment |
|
| Catheter Site Inflammation | General disorders | MedDra 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDra 11.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 11.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDra 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 11.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 11.0 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDra 11.0 | Systematic Assessment |
|
| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDra 11.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDra 11.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDra 11.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDra 11.0 | Systematic Assessment |
|
| Cold Sweat | Skin and subcutaneous tissue disorders | MedDra 11.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDra 11.0 | Systematic Assessment |
|
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Serum chemistry |
|
| Coagulation |
|
| Baseline QRS interval |
|
| Change from Baseline at Day 2 QRS interval |
|
| Baseline QT interval |
|
| Change from Baseline at Day 2 QT interval |
|
| Baseline QTc interval |
|
| Change from Baseline at Day 2 QTc interval |
|
| 12 Hours Post-dose |
|
| 24 Hours Post-dose |
|