Trial Outcomes & Findings for Renal Impairment Study of PF-06700841 (NCT NCT04260464)

NCT ID: NCT04260464

Last Updated: 2024-01-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
• Results posted on: 2024-01-22

Participant Flow

Healthy adult participants with normal renal function and adult participants with renal impairment were enrolled in this study.

A total of 30 participants who met the eligibility criteria were assigned and treated.

Participant milestones

Measure	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.	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.	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.	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.
Overall Study STARTED	8	7	7	8
Overall Study COMPLETED	8	7	7	8
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renal Impairment Study of PF-06700841

Baseline characteristics by cohort

Measure	Severe Renal Impairment n=8 Participants 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.	Normal Renal Function n=7 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Continuous Mean (SD)	65.9 Years STANDARD_DEVIATION 7.57 • n=5 Participants	62.4 Years STANDARD_DEVIATION 5.38 • n=7 Participants	68.4 Years STANDARD_DEVIATION 4.24 • n=5 Participants	61.5 Years STANDARD_DEVIATION 6.16 • n=4 Participants	64.5 Years STANDARD_DEVIATION 6.36 • n=21 Participants
Age, Customized 45-64 Years	3 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants
Age, Customized >=65 Years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	22 Participants n=21 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	27 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

Population: The PK concentration population is defined as all participants assigned to investigational product and treated who have at least 1 concentration measured.

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.

Outcome measures

Measure	Severe Renal Impairment n=8 Participants 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.	Normal Renal Function n=7 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.
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	303.2 ng/mL Geometric Coefficient of Variation 34	275.2 ng/mL Geometric Coefficient of Variation 27	341.8 ng/mL Geometric Coefficient of Variation 17	260.3 ng/mL Geometric Coefficient of Variation 89

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

Population: 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.

AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data.

Outcome measures

Measure	Severe Renal Impairment n=8 Participants 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.	Normal Renal Function n=6 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.
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	2013 ng*hr/mL Geometric Coefficient of Variation 57	1796 ng*hr/mL Geometric Coefficient of Variation 77	2652 ng*hr/mL Geometric Coefficient of Variation 75	1274 ng*hr/mL Geometric Coefficient of Variation 199

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

Population: The PK concentration population is defined as all participants assigned to investigational product and treated who have at least 1 concentration measured.

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.

Outcome measures

Measure	Severe Renal Impairment n=8 Participants 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.	Normal Renal Function n=7 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.
Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function	250.4 ng/mL Geometric Coefficient of Variation 26	141.0 ng/mL Geometric Coefficient of Variation 32	172.1 ng/mL Geometric Coefficient of Variation 46	187.1 ng/mL Geometric Coefficient of Variation 43

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

Population: 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.

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.

Outcome measures

Measure	Severe Renal Impairment n=7 Participants 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.	Normal Renal Function n=7 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.
AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function	7756 ng*hr/mL Geometric Coefficient of Variation 41	1739 ng*hr/mL Geometric Coefficient of Variation 24	3984 ng*hr/mL Geometric Coefficient of Variation 15	2515 ng*hr/mL Geometric Coefficient of Variation 32

SECONDARY outcome

Timeframe: From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)

Population: The analysis population included all assigned to investigational product and who take at least 1 dose of investigational product.

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.

Outcome measures

Measure	Severe Renal Impairment n=8 Participants 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.	Normal Renal Function n=7 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Participants with adverse events	2 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Participants with serious adverse events	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Participants with severe adverse events	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Participants discontinued from study due to adverse events	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 4

Population: The analysis population included all participants assigned to investigational product and who take at least 1 dose of investigational product.

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.

Outcome measures

Measure	Severe Renal Impairment n=8 Participants 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.	Normal Renal Function n=7 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Hematology-Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9✕LLN	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Hematology-Lymphocytes/Leukocytes (%) <0.8✕LLN	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Hematology-Lymphocytes/Leukocytes (%) >1.2✕ULN	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Hematology-Eosinophils/Leukocytes (%) >1.2✕ULN	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Clinical chemistry-Blood Urea Nitrogen (mg/dL) >1.3✕ULN	8 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Clinical chemistry-Creatinine (mg/dL) >1.3✕ULN	8 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Hematology-Hemoglobin (HGB) (g/dL) <0.8✕lower limit of normal (LLN)	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Hematology-Hematocrit (%) <0.8✕LLN	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Hematology-Erythrocytes (10^6/mm^3) <0.8✕LLN	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Hematology- Erythromycin (Ery.) Mean Corpuscular HGB (pg/cell) >1.1✕upper limit of normal (ULN)	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Clinical chemistry-Urate (mg/dL) > 1.2✕ULN	5 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Clinical chemistry-Potassium (mEq/L) >1.1✕ULN	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Clinical chemistry-Bicarbonate (mEq/L) <0.9✕LLN	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Clinical chemistry-Glucose (mg/dL) >1.5✕ULN	1 Participants	0 Participants	4 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Urinalysis-Urine Glucose ≥1	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Urinalysis-Urine Protein ≥1	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Urinalysis-Urine Hemoglobin ≥1	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality Urinalysis-Urine Leukocyte Esterase ≥1	1 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 4

Population: The analysis population included all assigned to investigational product and who take at least 1 dose of investigational product.

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.

Outcome measures

Measure	Severe Renal Impairment n=8 Participants 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.	Normal Renal Function n=7 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.
Number of Participants With Post-baseline Vital Sign Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4

Population: All assigned to investigational product and who take at least 1 dose of investigational product.

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.

Outcome measures

Measure	Severe Renal Impairment n=8 Participants 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.	Normal Renal Function n=7 Participants 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.	Moderate Renal Impairment n=7 Participants 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.	Mild Renal Impairment n=8 Participants 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.
Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities QTcB interval, single beat (msec): 450 < Value ≤ 480	2 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities QTcB interval, single beat (msec): 30 ≤ Change ≤ 60	0 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities QTcF interval, single beat (msec): 450 < Value ≤ 480	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities QTcF interval, single beat (msec): 30 ≤ Change ≤ 60	0 Participants	0 Participants	0 Participants	2 Participants

Adverse Events

Severe Renal Impairment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal Renal Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate Renal Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Mild Renal Impairment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Severe Renal Impairment n=8 participants at risk 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.	Normal Renal Function n=7 participants at risk 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.	Moderate Renal Impairment n=7 participants at risk 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.	Mild Renal Impairment n=8 participants at risk 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.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	12.5% 1/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Gastrointestinal disorders Nausea	12.5% 1/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	14.3% 1/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Infections and infestations Diverticulitis	0.00% 0/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	12.5% 1/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	12.5% 1/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Nervous system disorders Dizziness	12.5% 1/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Nervous system disorders Headache	0.00% 0/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	0.00% 0/7 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)	12.5% 1/8 • From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place