Anorexia, Breast Cancer, Cachexia, Colorectal Cancer, Fatigue, Loss of Appetite, Non-small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
Conditions
Keywords
cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
Brief summary
Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under the skin) doses.
Detailed description
A 6 week double blind study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated doses injected under the skin (subcutaneously). During the initial 6-week treatment period (Part A), a total of 2 doses of study drug or placebo will be administered 3 weeks apart. Each dose contains two injections. Part B is an optional 18-week open-label treatment period where up to 7 doses of study drug may be administered. Part B does not include placebo. Assessments include: * Measure the impact of the study drug on appetite, fatigue, and pain questionnaires * Body weight measurements * Blood samples to evaluate safety and additional endpoints including the amount of the study drug in the blood and the effects of the study drug on levels of a specific cytokine.
Interventions
DRUGPF-06946860
subcutaneous injection
DRUGPlacebo for PF-06946860
subcutaneous injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered advanced. * Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale * Meets any of the following criteria at Randomization: * Not currently receiving antineoplastic therapy * On standard of care systemic antineoplastic therapy or treatment without curative intent * Signed informed consent. Key
Exclusion criteria
* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization. * Current active reversible causes of decreased food intake. * Current, severe gastrointestinal disease * Participants with known symptomatic brain metastases requiring steroids. * Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or participants with known AIDS-related illness * inadequate renal or liver function. * Women who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A | Baseline, Week 4 | The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-no appetite to 10-very good appetite, where higher score indicated better appetite. In this Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Baseline, Weeks 1, 2, 3, 5 and 6 | The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-no appetite to 10-very good appetite, where higher score indicated better appetite. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint. |
| Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Baseline, Weeks 1, 2, 3, 4, 5 and 6 | The Cancer-Related Cachexia Symptom Assessment-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-no fatigue to 10-worst possible fatigue, where higher score indicated worse fatigue. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue score were summarized descriptively by treatment group and timepoint. |
| Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A | Day 1 through Week 6 (for a period of 6 weeks) | An 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. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. |
| Number of Participants With Laboratory Test Abnormalities in Part A | Days 1, 22 and 43 | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes \[/high power field (HPF)\], urine leukocytes \[/HPF\] and hyaline casts \[/low power field (LPF)\]). |
Countries
Canada, United States
Participant flow
Pre-assignment details
A total of 18 participants were enrolled into the study and treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo -> OL PF-06946860 200mg Q3W Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively. | 6 |
| PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively. | 12 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part A: 6-week Double-blind Treatment | Death | 0 | 2 |
| Part A: 6-week Double-blind Treatment | Physician Decision | 1 | 0 |
| Part A: 6-week Double-blind Treatment | Withdrawal by Subject | 0 | 1 |
| Part B: OLT Period up to 18 Weeks | Adverse Event | 1 | 0 |
| Part B: OLT Period up to 18 Weeks | Death | 1 | 2 |
| Part B: OLT Period up to 18 Weeks | Other | 0 | 1 |
| Part B: OLT Period up to 18 Weeks | Physician Decision | 0 | 1 |
| Part B: OLT Period up to 18 Weeks | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo -> OL PF-06946860 200mg Q3W | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | Total |
|---|---|---|---|
| Age, Continuous | 68.0 Years STANDARD_DEVIATION 7.95 | 74.0 Years STANDARD_DEVIATION 9.12 | 72.0 Years STANDARD_DEVIATION 8.99 |
| Age, Customized <18 | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 18-44 | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 45-64 | 2 Participants | 2 Participants | 4 Participants |
| Age, Customized >=65 | 4 Participants | 10 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 11 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 11 Participants | 14 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 6 | 2 / 12 | 2 / 6 | 4 / 12 |
| other Total, other adverse events | 4 / 6 | 4 / 12 | 6 / 6 | 8 / 12 |
| serious Total, serious adverse events | 1 / 6 | 3 / 12 | 2 / 6 | 5 / 12 |
Outcome results
Primary
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-no appetite to 10-very good appetite, where higher score indicated better appetite. In this Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.
Time frame: Baseline, Week 4
Population: The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed/number analyzed = number of participants evaluable for this OM in each treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A | 2.45 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A | 1.84 Units on a Scale |
90% CI: [-2.38, 1.18]
Secondary
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A
The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-no appetite to 10-very good appetite, where higher score indicated better appetite. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint.
Time frame: Baseline, Weeks 1, 2, 3, 5 and 6
Population: The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 2 | 1.11 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 5 | 1.95 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 3 | 1.27 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 6 | 2.41 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 1 | 0.99 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 6 | 1.61 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 1 | 2.19 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 2 | 2.21 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 3 | 2.30 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Week 5 | 1.95 Units on a Scale |
90% CI: [-0.75, 3.15]
90% CI: [-0.28, 2.49]
90% CI: [-0.93, 2.99]
90% CI: [-2.02, 2.02]
90% CI: [-3.11, 1.51]
Secondary
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A
The Cancer-Related Cachexia Symptom Assessment-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-no fatigue to 10-worst possible fatigue, where higher score indicated worse fatigue. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue score were summarized descriptively by treatment group and timepoint.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5 and 6
Population: The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 2 | 0.04 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 4 | -1.00 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 1 | 1.84 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 5 | -0.92 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 3 | -1.21 Units on a Scale |
| Placebo | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 6 | -1.13 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 3 | -0.49 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 1 | 1.52 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 2 | -2.12 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 6 | 0.74 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 4 | -0.55 Units on a Scale |
| PF-06946860 200mg Q3W | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Week 5 | -0.24 Units on a Scale |
90% CI: [-4.18, 3.53]
90% CI: [-5.49, 1.16]
90% CI: [-0.62, 2.06]
90% CI: [-1.29, 2.2]
90% CI: [-1.21, 2.57]
90% CI: [0.34, 3.39]
Secondary
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A
An 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. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
Time frame: Day 1 through Week 6 (for a period of 6 weeks)
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A | Participants With All-Causality TEAEs | 4 Participants |
| Placebo | Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A | Participants With All-Causality SAEs | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A | Participants With All-Causality TEAEs | 7 Participants |
| PF-06946860 200mg Q3W | Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A | Participants With All-Causality SAEs | 3 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities in Part A
Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes \[/high power field (HPF)\], urine leukocytes \[/HPF\] and hyaline casts \[/low power field (LPF)\]).
Time frame: Days 1, 22 and 43
Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose <0.6 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | pH <4.5 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bilirubin >=1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Erythrocytes (/HPF) >=20 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin <0.8 x lower limit of normal (LLN) | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit <0.8 x LLN | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes <0.8 x LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Volume <0.9 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Volume >1.1 x upper limit of normal (ULN) | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Hemoglobin <0.9 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Hemoglobin >1.1 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Hemoglobin Concentration <0.9 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Hemoglobin Concentration >1.1 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets <0.5 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Leukocytes <0.6 x LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets >1.75 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Leukocytes >1.5 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes <0.8 x LLN | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Bilirubin >1.5 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase >3.0 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase >3.0 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Protein <0.8 x LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Protein >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin <0.8 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen >1.3 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine >1.3 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Urate >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium <0.95 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium <0.9 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium >1.1 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride <0.9 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride >1.1 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium <0.9 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium >1.1 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Bicarbonate <0.9 x LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Bicarbonate >1.1 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium >1.05 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose >1.5 x ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | pH >8 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Glucose >=1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Ketones >=1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein >=1 | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hemoglobin >=1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Urobilinogen >=1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Nitrite >=1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Leukocyte Esterase >=1 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities in Part A | Hyaline Casts (/LPF) >1 | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Urobilinogen >=1 | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin >1.2 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose >1.5 x ULN | 2 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen >1.3 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | pH <4.5 | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin <0.8 x lower limit of normal (LLN) | 4 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine >1.3 x ULN | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit <0.8 x LLN | 3 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bilirubin >=1 | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes <0.8 x LLN | 4 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Urate >1.2 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Volume <0.9 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | pH >8 | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Volume >1.1 x upper limit of normal (ULN) | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium <0.95 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Hemoglobin <0.9 x LLN | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium >1.05 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Hemoglobin >1.1 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Hyaline Casts (/LPF) >1 | 2 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Hemoglobin Concentration <0.9 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium <0.9 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Erythrocytes Mean Corpuscular Hemoglobin Concentration >1.1 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Glucose >=1 | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium >1.1 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets <0.5 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Nitrite >=1 | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets >1.75 x ULN | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Leukocytes <0.6 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride <0.9 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Leukocytes >1.5 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Ketones >=1 | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes <0.8 x LLN | 6 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride >1.1 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes >1.2 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Leukocytes (/HPF) >=20 | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils >1.2 x ULN | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium <0.9 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils >1.2 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein >=1 | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes >1.2 x ULN | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium >1.1 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Bilirubin >1.5 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Leukocyte Esterase >=1 | 2 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Bicarbonate <0.9 x LLN | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase >3.0 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hemoglobin >=1 | 2 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase >3.0 x ULN | 2 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Bicarbonate >1.1 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Protein <0.8 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Erythrocytes (/HPF) >=20 | 1 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Protein >1.2 x ULN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose <0.6 x LLN | 0 Participants |
| PF-06946860 200mg Q3W | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin <0.8 x LLN | 0 Participants |