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This study is intended to assess the relative bioavailability between the (extended-release) ER8 capsule formulation (the formulation that is currently used for verinurad development) given under fasted conditions and 2 new capsule formulations of verinurad (A-capsule and B-capsule) given under fed or fasted conditions. All three capsules target an 8-hour release profile (extended-release). The highest dose (12 mg) currently tested in participants will be tested in this study. The study is designed to provide information to optimize the verinurad part of a fixed dose combination capsule to be used in future development.
This study will be a randomised, open-label, single-dose, 5-period, 5-treatment, crossover study in healthy male and female participants, performed at a single study centre. This study is intended to assess the relative bioavailability between the ER8 capsule formulation (the formulation that is currently used for verinurad development) given under fasted conditions and 2 new capsule formulation of verinurad (A-capsule and B-capsule) given under fed or fasted conditions. All three capsules target an 8-hour release profile (extended-release). The highest dose (12 mg) currently tested in participants will be tested in this study. The study is designed to provide information to optimize the verinurad part of a fixed dose combination capsule to be used in future development. The study will comprise: a screening period of maximum 28 days; five treatment periods during which participants will be resident from the morning of the day before dosing with verinurad (Day -1) until at least 72 hours after dosing; discharged on the morning of Day 4 of each Treatment Period; and a follow-up Visit within 7 to 14 days after the last administration of verinurad. There will be a minimum washout period of 5 days between each dose administration. A total of 25 healthy male and female participants will be randomised into this study. Each participant will receive five single-dose treatments of 12 mg verinurad with 240 mL water, following an overnight fast of at least 10 hours. Participants will follow an overnight fast of at least 10 hours before the dosing procedures: for the fed dosing, a high-fat, high-calorie standard breakfast will be served 30 minutes before the planned administration of verinurad to be consumed in full at least 5 minutes before dosing; for the fasted dosing, no breakfast will be served. A meal can be given 4 hours after administration of verinurad for both dosing states. The duration of the study is expected to be approximately 9 weeks for each individual participant (including the 28-day screening period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state. |
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| Treatment 2 | Experimental | During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state. |
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| Treatment 3 | Experimental | During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state. |
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| Treatment 4 | Experimental | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
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| Treatment 5 | Experimental | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verinurad ER8 capsule formulation (fasted) | Drug | Each participant will receive single-dose treatment of 12 mg verinurad ER8 capsule with 240 mL water, following an overnight fast of at least 10 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC) | To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| AUC From Time 0 to the Last Quantifiable Concentration (AUC0-t) for the Analysis of PK Parameter | To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter | To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC From Time 0 to 24 Hours Post Dose (AUC0-24) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | Pre-dose and up to 24-hours Post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for the Analysis of PK Parameter |
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Inclusion Criteria:
(1) not pregnant or currently lactating or breastfeeding. (2) of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: (i) postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range (FSH levels > 40 IU/mL).
(ii) documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
(3) OR if of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy for the entire study period.
Exclusion Criteria:
(1) Heart rate (resting, supine) < 50 beats per minute (bpm) or > 85 bpm, (2) Systolic BP < 90 mmHg or > 140 mmHg and/or diastolic BP < 50 mmHg or > 90 mmHg sustained for > 10 min while resting in a supine position.
6. Any clinically significant abnormalities on 12-lead Electrocardiogram (ECG) at the Screening Visit, including, but not limited to any of the following:
8. Suspicion or known Gilbert's and/or Lesch-Nyhan syndrome. 9. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for women.
10. Has received another new chemical entity (defined as a compound which has not been approved for marketing in the US) within 30 days or at least 5 half-lives (whichever is longer) of the first administration of verinurad in this study.
11. Participants who have previously received verinurad. 12. Plasma donation within 1 month of screening or any blood donation/loss of more than 500 mL during the 3 months prior to the Screening Visit.
13. Participants who are pregnant, lactating or planning to become pregnant. 14. History of severe allergy/hypersensitivity or ongoing clinically relevant allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to verinurad.
15. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
16. Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the PI. Excessive intake of caffeine defined as regular consumption of more than 600 mg of caffeine per day (e.g., > 5 cups of coffee) or would likely be unable to refrain from the use of caffeine containing beverages during confinement at the investigational site.
17. Positive screen for drugs of abuse or cotinine (nicotine) at the Screening Visit or positive screen for alcohol, drugs of abuse and cotinine on each admission to the study centre.
18. Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of verinurad.
19. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of verinurad or longer if the medication has a long half-life. The use of hormonal contraception therapy and hormonal replacement therapy for females are permitted.
20. Any AstraZeneca, PAREXEL or study site employee or their close relatives. 21. Participants who cannot communicate reliably with the PI and/or is not able to read, speak and understand the German language.
22. Judgment by the PI that the participant should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
23. Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
24. Participants with any special dietary restrictions such as participants that are lactose intolerant or are vegetarians/vegans.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 14050 | Germany |
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| Label | URL |
|---|---|
| redacted CSP and SAP | View source |
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The study included a Screening Period of maximum 28 days.
All subjects signed and dated the informed consent form (ICF) before any study procedures were performed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall-All Subjects | All subjects were randomized into 5-period, 5-treatment, crossover study to receive a single oral dose of 12 mg verinurad:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2019 |
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| Verinurad A-capsule formulation (fasted) | Drug | Each participant will receive single-dose treatment of 12 mg verinurad A-capsule with 240 mL water, following an overnight fast of at least 10 hours. |
|
| Verinurad A-capsule formulation (fed) | Drug | Each participant will receive single dose treatment of 12 mg verinurad A-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast). |
|
| Verinurad B-capsule formulation (fasted) | Drug | Each participant will receive single-dose treatment of 12 mg verinurad B-capsule with 240 mL water, following an overnight fast of at least 10 hours. |
|
| Verinurad B-capsule formulation (fed) | Drug | Each participant will receive single dose treatment of 12 mg verinurad B-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast). |
|
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. |
| Day 1: Pre-dose and up to 72-hour Post-dose |
| Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRT) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| Time of Last Quantifiable Plasma Concentration (Tlast) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| Volume of Distribution at Steady State (Intravenous Dosing) (Vss/F) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | Day 1: Pre-dose and up to 72-hour Post-dose |
| Number of Participants With Adverse Events (AEs) | To assess AEs as variable of safety and tolerability of single doses of verinurad in healthy participants. | From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose) |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall-All Subjects | All subjects were randomized into 5-period, 5-treatment, crossover study to receive a single oral dose of 12 mg verinurad:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC) | To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1: Pre-dose and up to 72-hour Post-dose |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | AUC From Time 0 to the Last Quantifiable Concentration (AUC0-t) for the Analysis of PK Parameter | To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter | To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC From Time 0 to 24 Hours Post Dose (AUC0-24) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose and up to 24-hours Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Median | Full Range | Hour | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Mean | Standard Deviation | Hour | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Mean | Standard Deviation | Litre/hour | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRT) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Mean | Standard Deviation | Hour | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time of Last Quantifiable Plasma Concentration (Tlast) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Median | Full Range | Hour | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution at Steady State (Intravenous Dosing) (Vss/F) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Mean | Standard Deviation | Litre | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for the Analysis of PK Parameter | To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions. | The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Mean | Standard Deviation | Litre | Day 1: Pre-dose and up to 72-hour Post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | To assess AEs as variable of safety and tolerability of single doses of verinurad in healthy participants. | All subjects who received at least 1 dose of verinurad (any formulation) were included in the safety analysis for the study. | Posted | Count of Participants | Participants | From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose) |
|
From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
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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 | Treatment 1: 1 x 12 mg ER8 Capsule Fasted | During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state. | 0 | 25 | 0 | 25 | 5 | 25 |
| EG001 | Treatment 2: 2 x 6 mg A-capsule Fasted | During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state. | 0 | 25 | 0 | 25 | 6 | 25 |
| EG002 | Treatment 3: 2 x 6 mg A-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state. | 0 | 25 | 0 | 25 | 2 | 25 |
| EG003 | Treatment 4: 2 x 6 mg B-capsule Fasted | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. | 0 | 25 | 0 | 25 | 4 | 25 |
| EG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. | 0 | 25 | 0 | 25 | 3 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
This confidential document is the property of AstraZeneca AB. No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB. Access to this document must be restricted to relevant parties.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca information Centre | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Aug 4, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
Not provided
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mixed Model Analysis |
The number of subjects in this analysis: 22 |
| Geometric mean ratio |
| 50.02 |
| 2-Sided |
| 90 |
| 42.34 |
| 59.10 |
| Other |
| Pairwise comparison: Treatment 3/Treatment 2 | Mixed Model Analysis | The number of subjects in this analysis: 15 | Geometric mean ratio | 47.10 | 2-Sided | 90 | 39.85 | 55.68 | Other |
| Pairwise comparison: Treatment 3/Treatment 4 | Mixed Model Analysis | The number of subjects in this analysis: 15 | Geometric mean ratio | 58.40 | 2-Sided | 90 | 49.49 | 68.92 | Other |
| Pairwise comparison: Treatment 4/Treatment 1 | Mixed Model Analysis | The number of subjects in this analysis: 21 | Geometric mean ratio | 85.65 | 2-Sided | 90 | 73.78 | 99.43 | Other |
| Pairwise comparison: Treatment 4/Treatment 2 | Mixed Model Analysis | The number of subjects in this analysis: 21 | Geometric mean ratio | 80.65 | 2-Sided | 90 | 69.48 | 93.62 | Other |
| Pairwise comparison: Treatment 5/Treatment 1 | Mixed Model Analysis | The number of subjects in this analysis: 21 | Geometric mean ratio | 89.88 | 2-Sided | 90 | 77.61 | 104.09 | Other |
| Pairwise comparison: Treatment 5/Treatment 2 | Mixed Model Analysis | The number of subjects in this analysis: 21 | Geometric mean ratio | 84.64 | 2-Sided | 90 | 72.94 | 98.20 | Other |
| Pairwise comparison: Treatment 5/Treatment 3 | Mixed Model Analysis | The number of subjects in this analysis: 21 | Geometric mean ratio | 179.68 | 2-Sided | 90 | 151.57 | 212.99 | Other |
| Pairwise comparison: Treatment 5/Treatment 4 | Mixed Model Analysis | The number of subjects in this analysis: 21 | Geometric mean ratio | 104.94 | 2-Sided | 90 | 90.18 | 122.11 | Other |
| OG003 | Treatment 4: 2 x 6 mg B-capsule Fasted | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
|
| OG003 | Treatment 4: 2 x 6 mg B-capsule Fasted | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
|
| Treatment 4: 2 x 6 mg B-capsule Fasted |
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
| Treatment 4: 2 x 6 mg B-capsule Fasted |
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
| OG003 |
| Treatment 4: 2 x 6 mg B-capsule Fasted |
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
| OG003 |
| Treatment 4: 2 x 6 mg B-capsule Fasted |
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
| OG003 |
| Treatment 4: 2 x 6 mg B-capsule Fasted |
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
| Treatment 4: 2 x 6 mg B-capsule Fasted |
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
| Treatment 4: 2 x 6 mg B-capsule Fasted |
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
| OG003 |
| Treatment 4: 2 x 6 mg B-capsule Fasted |
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|
During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
| OG004 | Treatment 5: 2 x 6 mg B-capsule Fed | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
|
|