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The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.
This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06700841 after a single oral dose of 30 mg. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 4 will be a maximum of 32 days and from Screening visit to Follow-up/Contact Visit will a maximum of 67 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06700841 Severe Renal Impairment | Experimental | This arm includes participants with severe renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 |
|
| PF-06700841 Normal Renal Function | Experimental | This arm includes participants with normal renal function who will receive a single oral dose of 30 mg PF-06700841 on Day 1 |
|
| PF-06700841 Moderate Renal Impairment | Experimental | This arm includes participants with moderate renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 |
|
| PF-06700841 Mild Renal Impairment | Experimental | This arm includes participants with mild renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06700841 | Drug | A single dose of 30 mg PF-06700841 will be administered on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function | Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data. | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose |
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function | AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data. | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose |
| Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function | Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data. | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose |
| AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function | AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data. | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any events occurring following start of treatment or increasing in severity after the start of the treatment were counted as treatment emergent. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect. Severe adverse events is an event that prevents normal everyday activities which is a category utilized for rating the intensity of an event. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy | Miami | Florida | 33136 | United States | ||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 30 participants who met the eligibility criteria were assigned and treated.
Healthy adult participants with normal renal function and adult participants with renal impairment were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Severe Renal Impairment | Participants with estimated glomerular filtration rate (eGFR) <30 ml/min and not requiring dialysis were categorized into the severe renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 x 5 mg and 1 x 25 mg) orally. |
| FG001 | Normal Renal Function | Participants with eGFR ≥90 mL/min were categorized into the normal renal function arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
| FG002 | Moderate Renal Impairment | Participants with eGFR ≥30 to <60 mL/min were categorized into the moderate renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
| FG003 | Mild Renal Impairment | Participants with eGFR ≥60 to <89 mL/min were categorized into the mild renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants who were assigned to investigational product and took at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Severe Renal Impairment | Participants with eGFR <30 ml/min and not requiring dialysis were categorized into the severe renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 x 5 mg and 1 x 25 mg) orally. |
| BG001 | Normal Renal Function |
| 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 | Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function | Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data. | The PK concentration population is defined as all participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose |
|
From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
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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 | Severe Renal Impairment | Participants with eGFR <30 ml/min and not requiring dialysis were categorized into the severe renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 x 5 mg and 1 x 25 mg) orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2019 | Apr 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2020 | Apr 17, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000630838 | PF-06700841 |
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Single group
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No Masking
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| From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days) |
| Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality | The hematology, clinical chemistry and urinalysis abnormalities were summarized in accordance with the sponsor reporting standards without regard to baseline abnormality. Baseline is defined as the last planned predose measurement taken on Day -1. | Baseline (Day -1) and Day 4 |
| Number of Participants With Post-baseline Vital Sign Abnormalities | Vital Signs were assessed against the criteria specified in the sponsor reporting standards for potential clinical concerns. Vital sign abnormalities criteria included: 1) Systolic blood pressure (BP) in millimeters of mercury (mmHg): <90 mmHg with increase or decrease from baseline of ≥30 mmHg with high and low post baseline values; 2) Diastolic blood pressure (BP) (mmHg): <50 mmHg with increase or decrease from baseline of ≥20 mmHg with high and low post baseline values; 3) Supine pulse rate in beats per minutes (bpm): >120 or <40 bpm. Categories with at least 1 participant having vital sign abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1. | Baseline (Day 1) and Day 4 |
| Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): > 450, >480, >500, increase from baseline >30, increase from baseline >60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): >450, >480, >500, increase from baseline >30, increase from baseline >60. Categories with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1. | 0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4 |
| University of Miami Division of Clinical Pharmacology |
| Miami |
| Florida |
| 33136 |
| United States |
| Prism Research LLC dba Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
Participants with eGFR ≥90 mL/min were categorized into the normal renal function arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
| BG002 | Moderate Renal Impairment | Participants with eGFR ≥30 to <60 mL/min were categorized into the moderate renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
| BG003 | Mild Renal Impairment | Participants with eGFR ≥60 to <89 mL/min were categorized into the mild renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG001 | Normal Renal Function | Participants with eGFR ≥90 mL/min were categorized into the normal renal function arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
| OG002 | Moderate Renal Impairment | Participants with eGFR ≥30 to <60 mL/min were categorized into the moderate renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
| OG003 | Mild Renal Impairment | Participants with eGFR ≥60 to <89 mL/min were categorized into the mild renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function | AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data. | The PK parameter analysis population is defined as all participants assigned to investigational product and treated who have at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose |
|
|
|
|
| Primary | Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function | Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data. | The PK concentration population is defined as all participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose |
|
|
|
|
| Primary | AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function | AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data. | The PK parameter analysis population is defined as all participants assigned to investigational product and treated who have at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose |
|
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any events occurring following start of treatment or increasing in severity after the start of the treatment were counted as treatment emergent. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect. Severe adverse events is an event that prevents normal everyday activities which is a category utilized for rating the intensity of an event. | The analysis population included all assigned to investigational product and who take at least 1 dose of investigational product. | Posted | Count of Participants | Participants | From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days) |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality | The hematology, clinical chemistry and urinalysis abnormalities were summarized in accordance with the sponsor reporting standards without regard to baseline abnormality. Baseline is defined as the last planned predose measurement taken on Day -1. | The analysis population included all participants assigned to investigational product and who take at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day -1) and Day 4 |
|
|
|
| Secondary | Number of Participants With Post-baseline Vital Sign Abnormalities | Vital Signs were assessed against the criteria specified in the sponsor reporting standards for potential clinical concerns. Vital sign abnormalities criteria included: 1) Systolic blood pressure (BP) in millimeters of mercury (mmHg): <90 mmHg with increase or decrease from baseline of ≥30 mmHg with high and low post baseline values; 2) Diastolic blood pressure (BP) (mmHg): <50 mmHg with increase or decrease from baseline of ≥20 mmHg with high and low post baseline values; 3) Supine pulse rate in beats per minutes (bpm): >120 or <40 bpm. Categories with at least 1 participant having vital sign abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1. | The analysis population included all assigned to investigational product and who take at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day 1) and Day 4 |
|
|
|
| Secondary | Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): > 450, >480, >500, increase from baseline >30, increase from baseline >60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): >450, >480, >500, increase from baseline >30, increase from baseline >60. Categories with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1. | All assigned to investigational product and who take at least 1 dose of investigational product. | Posted | Count of Participants | Participants | 0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Normal Renal Function | Participants with eGFR ≥90 mL/min were categorized into the normal renal function arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Moderate Renal Impairment | Participants with eGFR ≥30 to <60 mL/min were categorized into the moderate renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG003 | Mild Renal Impairment | Participants with eGFR ≥60 to <89 mL/min were categorized into the mild renal impairment arm. Participants received a single dose of PF-06700841 30 mg tablets (2 tablets as 1 × 5 mg and 1 × 25 mg) orally. | 0 | 8 | 0 | 8 | 3 | 8 |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model. |
| Test/Reference Ratio |
| 70.97 |
| 2-Sided |
| 90 |
| 27.60 |
| 182.49 |
| Other |
| ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model. | Test/Reference Ratio | 147.70 | 2-Sided | 90 | 75.17 | 290.21 | Other |
ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model. |
| Test/Reference Ratio |
| 132.69 |
| 2-Sided |
| 90 |
| 95.08 |
| 185.17 |
| Other |
| ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model. | Test/Reference Ratio | 122.04 | 2-Sided | 90 | 84.47 | 176.30 | Other |
ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model. |
| Test/Reference Ratio |
| 144.63 |
| 2-Sided |
| 90 |
| 112.76 |
| 185.50 |
| Other |
| ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model. | Test/Reference Ratio | 229.12 | 2-Sided | 90 | 189.97 | 276.35 | Other |
| Participants with serious adverse events |
|
| Participants with severe adverse events |
|
| Participants discontinued from study due to adverse events |
|
| Hematology-Hematocrit (%) <0.8✕LLN |
|
| Hematology-Erythrocytes (10^6/mm^3) <0.8✕LLN |
|
| Hematology- Erythromycin (Ery.) Mean Corpuscular HGB (pg/cell) >1.1✕upper limit of normal (ULN) |
|
| Hematology-Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9✕LLN |
|
| Hematology-Lymphocytes/Leukocytes (%) <0.8✕LLN |
|
| Hematology-Lymphocytes/Leukocytes (%) >1.2✕ULN |
|
| Hematology-Eosinophils/Leukocytes (%) >1.2✕ULN |
|
| Clinical chemistry-Blood Urea Nitrogen (mg/dL) >1.3✕ULN |
|
| Clinical chemistry-Creatinine (mg/dL) >1.3✕ULN |
|
| Clinical chemistry-Urate (mg/dL) > 1.2✕ULN |
|
| Clinical chemistry-Potassium (mEq/L) >1.1✕ULN |
|
| Clinical chemistry-Bicarbonate (mEq/L) <0.9✕LLN |
|
| Clinical chemistry-Glucose (mg/dL) >1.5✕ULN |
|
| Urinalysis-Urine Glucose ≥1 |
|
| Urinalysis-Urine Protein ≥1 |
|
| Urinalysis-Urine Hemoglobin ≥1 |
|
| Urinalysis-Urine Leukocyte Esterase ≥1 |
|
| QTcB interval, single beat (msec): 30 ≤ Change ≤ 60 |
|
| QTcF interval, single beat (msec): 450 < Value ≤ 480 |
|
| QTcF interval, single beat (msec): 30 ≤ Change ≤ 60 |
|