STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOS... | NCT05093205

Label	Type	Description	Intervention Names
Part A	Experimental	To evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of atorvastatin (20 mg tablet) and midazolam (5 mg syrup).	Drug: PF-06882961 Drug: Atorvastatin Drug: Midazolam
Part B	Experimental	To evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of an Oral Contraceptive (Levonorgestrel 0.15 mg and Ethinyl Estradiol 0.03 mg tablet).	Drug: PF-06882961 Drug: Levonorgestrel & Ethinyl Estradiol

Name	Type	Description	Arm Group Labels	Other Names
PF-06882961	Drug	Tablets	Part A Part B
Atorvastatin

Measure	Description	Time Frame
(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7	Atorvastatin was given on Day 1 in Periods 1, 4 and 7 of Part A and blood samples were collected for atorvastatin pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.	For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.
(Part A) AUCinf of Midazolam in Periods 2, 5, and 8	Midazolam was given on Day 1 in Periods 2, 5 and 8 of Part A and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.	For Part A Periods 2, 5, and 8: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (only for Periods 2 & 5) post midazolam dose on Day 1 of each period.
(Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5	Levonorgestrel was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for levonorgestrel PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.	For Part B Periods 1, 3, 5: At 0 (prior to levonorgestrel dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post levonorgestrel dose on Day 1 of each period.
(Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5	Ethinyl estradiol (EE) was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for ethinyl estradiol PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

Measure	Description	Time Frame
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study	An AE was 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. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Part A Only - Healthy male and female participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12 lead ECG and clinical laboratory tests).
Part B Only - Healthy PM female participants between 40 and 65 years of age, inclusive, at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including BP and PR measurement, standard 12 lead ECG and clinical laboratory tests). Subjects must be amenorrheic for at least 12 months. Women who are 60 years of age or younger must also have an FSH that is within the laboratory's reference range for PM women.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
BMI- 20.0 kg/m2 to <30.0 kg/m2 at Screening.
Stable body weight, defined as <5 % change (per participant report) for 90 days before Screening.
Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency).
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Known intolerance or hypersensitivity to GLP-1R agonists.
Known hypersensitivity to atorvastatin or midazolam (for participants in Part A), or LE and EE (for participants in Part B).
Personal or family history of MTC or MEN2 or study participants with suspected MTC per the investigator's judgment.
Symptomatic gallbladder disease.
History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years from screening.
Any lifetime history of a suicide attempt.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Systemic therapy with any of the medications that are moderate or strong CYP3A4/5, CYP2C9 and/or CYP2C19 inhibitors within 28 days or 5 half-lives (whichever is longer) or moderate or strong CYP3A, CYP2C9 and/or CYP2C19 inducers within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Systemic therapy with inhibitors of the BCRP transporter within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
Known prior participation in a trial involving PF-06882961.
A PHQ-9 score ≥15 obtained at Screening or Day -1 in Study.
Response of "yes" to question 4 or 5, or on any suicidal behavioral question on the C SSRS at Screening or Day -1 in Study.
A positive urine drug test.
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. BP should be measured in triplicate and the average of the 3 BP values should be used to determine the participant's eligibility. Note: At screening, the participant's arm circumference should be measured (eg, using a flexible anthropometric tape) at the midpoint of the length of the upper arm and the appropriate cuff selected and used throughout the study.
Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- HbA1c ≥6.5%.
- Aspartate AST or ALT level ≥2 times the ULN.
- Total bilirubin level ≥1.5 times the ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
- TSH >1.5x the ULN or <LLN.
- Serum calcitonin > the ULN.
- Amylase or lipase > the ULN.
- Fasting blood glucose ≥126 mg/dL.
- Fasting C-peptide <0.8 ng/mL.
- eGFR <70 mL/min/1.73 m2 as calculated by the CKD-EPI equation.
- Positive testing for HIV, HepBsAg, or HCVAb. Study participants positive for HCVAb are to be excluded unless known to have been treated with a known curative therapy and negative for HCV RNA. Hepatitis B vaccination is allowed.
- A positive SARS-CoV-2 test.
Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
Current use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
Known or suspected illicit drug use.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing randomization (Day-1).
History of sensitivity to heparin or heparin induced thrombocytopenia if Hep-lock is used for IV blood draw.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Anaheim Clinical Trials, LLC		Anaheim	California	92801	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Atorvastatin 20 mg (Part A Period 1)	Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
FG001	Midazolam 5 mg (Part A Period 2)	Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 30, 2021	Jun 15, 2023

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

(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7

Atorvastatin was given on Day 1 in Periods 1, 4 and 7 of Part A and blood samples were collected for atorvastatin pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

Only participants with evaluable results for the pharmacokinetic (PK) parameter were included in the analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram*hour/milliliter (ng*hr/mL)

For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.

ID	Title	Description
OG000	Atorvastatin 20 mg (Part A Period 1)	Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
OG001	PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)	Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
OG002	PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)	Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.

Units	Counts
Participants	OG00016 OG00111 OG0023

Title

Denominators

Categories

Title	Measurements
	OG00032.27± 41 OG00146.94± 72 OG00254.43± 22

Primary

(Part A) AUCinf of Midazolam in Periods 2, 5, and 8

Midazolam was given on Day 1 in Periods 2, 5 and 8 of Part A and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

Only participants with evaluable results for the PK parameter were included in the analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

For Part A Periods 2, 5, and 8: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (only for Periods 2 & 5) post midazolam dose on Day 1 of each period.

ID	Title	Description
OG000	Midazolam 5 mg (Part A Period 2)	Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.
OG001	PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)	Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
OG002	PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)	Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.

Primary

(Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5

Levonorgestrel was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for levonorgestrel PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

Only participants with evaluable results for the PK parameter were included in the analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

picogram*hour/milliliter (pg*hr/mL)

For Part B Periods 1, 3, 5: At 0 (prior to levonorgestrel dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post levonorgestrel dose on Day 1 of each period.

ID	Title	Description
OG000	0.15 mg LE & 0.03 mg EE (Part B Period 1)	Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
OG001	PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)	Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.
OG002	PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)	Participants received PF-06882961 200 mg BID + oral contraceptive SD on Day 1 and PF-06882961 200 mg BID on Days 2-5 of Period 5 in Part B.

Primary

(Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5

Ethinyl estradiol (EE) was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for ethinyl estradiol PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

Only participants with evaluable results for the PK parameter were included in the analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

pg*hr/mL

For Part B Periods 1, 3, 5: At 0 (prior to EE dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post EE dose on Day 1 in Periods 1, 3, 5 of each period.

ID	Title	Description
OG000	0.15 mg LE & 0.03 mg EE (Part B Period 1)	Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
OG001	PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)	Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.
OG002	PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)	Participants received PF-06882961 200 mg BID + oral contraceptive SD on Day 1 and PF-06882961 200 mg BID on Days 2-5 of Period 5 in Part B.

Secondary

(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study

An AE was 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. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.

All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From Baseline up to follow-up telephone contact (Days 90-97) in Part A of the study.

ID	Title	Description
OG000	Atorvastatin 20 mg (Part A Period 1)	Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
OG001	Midazolam 5 mg (Part A Period 2)	Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.

Secondary

(Part B) Number of Participants With TEAE During Part B of the Study

All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From Baseline up to follow-up telephone contact (Days 94-101) in Part B of the study.

ID	Title	Description
OG000	0.15 mg LE & 0.03 mg EE (Part B Period 1)	Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
OG001	PF-06882961 Titration up to 120 mg BID (Part B Period 2)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B.

Secondary

(Part A) Number of Participants With Clinical Laboratory Abnormalities During Part A of the Study (Without Regard to Baseline Abnormality)

Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.

All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From Baseline up to follow-up visit (Days 69-72) in Part A of the study.

ID	Title	Description
OG000	Atorvastatin 20 mg (Part A Period 1)	Participants received single dose of atorvastatin 20 mg orally on Day 1 of Period 1 in Part A.
OG001	Midazolam 5 mg (Part A Period 2)	Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.
OG002	PF-06882961 Titration up to 120 mg BID (Part A Period 3)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 3 in Part A.

Secondary

(Part B) Number of Participants With Clinical Laboratory Abnormalities During Part B of the Study (Without Regard to Baseline Abnormality)

Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.

All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From Baseline up to follow-up visit (Days 72-75) in Part B of the study.

ID	Title	Description
OG000	0.15 mg LE & 0.03 mg EE (Part B Period 1)	Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
OG001	PF-06882961 Titration up to 120 mg BID (Period 2)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B.
OG002	PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)	Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.

Secondary

(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study

Supine blood pressure (mm Hg) and pulse rate (beats per minute) were measured. Supine BP was measured with the participant's arm supported at heart level and recorded to the nearest mmHg after approximately 5 minutes of rest.

All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From Baseline up to follow-up visit (Days 69-72) in Part A of the study.

ID	Title	Description
OG000	Atorvastatin 20 mg (Part A Period 1)	Participants received single dose of atorvastatin 20 mg orally on Day 1 of Period 1 in Part A.
OG001	Midazolam 5 mg (Part A Period 2)	Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.
OG002	PF-06882961 Titration up to 120 mg BID (Part A Period 3)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 3 in Part A.

Secondary

(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study

Supine blood pressure (mm Hg) and pulse rate (bpm) were measured. Supine BP was measured with the participant's arm supported at heart level and recorded to the nearest mmHg after approximately 5 minutes of rest.

All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From Baseline up to follow-up visit (Days 72-75) in Part B of the study.

ID	Title	Description
OG000	0.15 mg LE & 0.03 mg EE (Part B Period 1)	Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
OG001	PF-06882961 Titration up to 120 mg BID (Part B Period 2)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B.
OG002	PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)	Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.

Secondary

(Part A) Percentage of Change From Baseline in Body Weight

Percentage of changes from Baseline in body weight of the participants were measured.

All participants who were randomly assigned to study intervention and had at least 1 dose of study intervention, and with evaluable body weight measurement were included in the analysis.

Posted

Mean

Standard Deviation

percentage

Percentage of change from Baseline 1: from the last pre-dose measurement in Part A Period 1 (ie, Baseline 1) to Day 2 of Part A Period 8; percentage of Change from the last predose measurement in Part A Period 3 (ie, Baseline 2) to Day 2 of Period 8.

ID	Title	Description
OG000	All Participants in Part A	Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: atorvastatin 20mg single dose (SD) on Day 1; Period 2: midazolam 5mg SD on Day 1; Period 3: PF-06882961 10mg twice daily (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 4: PF-06882961 120mg BID+atorvastatin SD on Day 1, PF-06882961 120mg on Days 2-3; Period 5: PF-06882961 120 mg BID+ midazolam SD on Day 1; Period 6: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 7: PF-06882961 200 mg BID+atorvastatin SD on Day 1, PF-06882961 200 mg BID on Days 2-3; Part 8: PF-06882961 200 mg BID+ midazolam SD on Day 1.

Secondary

(Part B) Percentage of Change From Baseline in Body Weight

Percentage of changes from Baseline in body weight of the participants were measured.

All participants who were randomly assigned to study intervention and had at least 1 dose of study intervention, and with evaluable body weight measurement were included in the analysis.

Posted

Mean

Standard Deviation

percentage

Percentage of Change from Baseline 1:from the last pre-dose measurement in Part B Period 1 (ie, Baseline 1) to Day 2 of Part B Period 8;percentage of Change from the last predose measurement in Part B Period 2 (ie, Baseline 2) to Day 6 of Part B Period 5.

ID	Title	Description
OG000	All Participants in Part B	Participants underwent Period 1 to 5 and received study interventions as follows: Period 1: oral contraceptive (OC) SD on Day 1; Period 2:PF-06882961 10mg BID on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 3: PF-06882961 120mg BID+OC SD on Day 1, PF-06882961 120mg on Days 2-5; Period 4: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 5: PF-06882961 200 mg BID+OC SD on Day 1, PF-06882961 200 mg BID on Days 2-5.

Units	Counts
Participants

Secondary

(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study

Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measured PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.

All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From Baseline up to follow-up visit (Days 69-72) in Part A of the study.

ID	Title	Description
OG000	Atorvastatin 20 mg (Part A Period 1)	Participants received single dose of atorvastatin 20 mg orally on Day 1 of Period 1 in Part A.
OG001	Midazolam 5 mg (Part A Period 2)	Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.
OG002	PF-06882961 Titration up to 120 mg BID (Part A Period 3)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 3 in Part A.

Secondary

(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study

All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From Baseline up to follow-up visit (Days 72-75) in Part B of the study.

ID	Title	Description
OG000	0.15 mg LE & 0.03 mg EE (Part B Period 1)	Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
OG001	PF-06882961 Titration up to 120 mg BID (Part B Period 2)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B.
OG002	PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)	Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.

Secondary

(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").

The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.

Posted

Count of Participants

Participants

Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.

ID	Title	Description
OG000	All Participants in Part A	Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: atorvastatin 20mg single dose (SD) on Day 1; Period 2: midazolam 5mg SD on Day 1; Period 3: PF-06882961 10mg twice daily (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 4: PF-06882961 120mg BID+atorvastatin SD on Day 1, PF-06882961 120mg on Days 2-3; Period 5: PF-06882961 120 mg BID+ midazolam SD on Day 1; Period 6: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 7: PF-06882961 200 mg BID+atorvastatin SD on Day 1, PF-06882961 200 mg BID on Days 2-3; Part 8: PF-06882961 200 mg BID+ midazolam SD on Day 1.

Secondary

(Part B) Number of Participants With Categorical Scores on the C-SSRS

The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.

Posted

Count of Participants

Participants

Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.

ID	Title	Description
OG000	All Participants in Part B	Participants underwent Period 1 to 5 and received study interventions as follows: Period 1: oral contraceptive (OC) SD on Day 1; Period 2:PF-06882961 10mg BID on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 3: PF-06882961 120mg BID+OC SD on Day 1, PF-06882961 120mg on Days 2-5; Period 4: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 5: PF-06882961 200 mg BID+OC SD on Day 1, PF-06882961 200 mg BID on Days 2-5.

Secondary

(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)

The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 [not at all] to 3 [nearly every day]. Higher score=greater severity).

The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	All Participants in Part A	Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: atorvastatin 20mg single dose (SD) on Day 1; Period 2: midazolam 5mg SD on Day 1; Period 3: PF-06882961 10mg twice daily (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 4: PF-06882961 120mg BID+atorvastatin SD on Day 1, PF-06882961 120mg on Days 2-3; Period 5: PF-06882961 120 mg BID+ midazolam SD on Day 1; Period 6: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 7: PF-06882961 200 mg BID+atorvastatin SD on Day 1, PF-06882961 200 mg BID on Days 2-3; Part 8: PF-06882961 200 mg BID+ midazolam SD on Day 1.

Secondary

(Part B) Number of Participants With Categorical Scores on the PHQ-9

The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	All Participants in Part B	Participants underwent Period 1 to 5 and received study interventions as follows: Period 1: oral contraceptive (OC) SD on Day 1; Period 2:PF-06882961 10mg BID on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 3: PF-06882961 120mg BID+OC SD on Day 1, PF-06882961 120mg on Days 2-5; Period 4: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 5: PF-06882961 200 mg BID+OC SD on Day 1, PF-06882961 200 mg BID on Days 2-5.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0025 affected17 at risk EG0030 affected13 at risk EG0041 affected13 at risk EG0052 affected13 at risk EG0060 affected5 at risk EG0070 affected6 at risk EG0080 affected17 at risk EG0097 affected16 at risk EG0101 affected14 at risk EG0114 affected12 at risk EG0123 affected9 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0026 affected17 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0022 affected17 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG00210 affected17 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0022 affected17 at risk EG003
Fatigue	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0023 affected17 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected17 at risk EG003
Dizziness	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0022 affected17 at risk EG003
Headache	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected18 at risk EG0023 affected17 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected17 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected17 at risk EG003
Feeling jittery	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Pyrexia	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Blood calcitonin increased	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected17 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0022 affected17 at risk EG003
Lethargy	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected17 at risk EG003
Tremor	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Initial insomnia	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Middle insomnia	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected17 at risk EG003
Dry eye	Eye disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Retching	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Ageusia	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Electric shock sensation	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Somnolence	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Abnormal dreams	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Self esteem decreased	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected17 at risk EG003

Title

Denominators

Categories

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things

- ParticipantsOG00017

Title	Measurements
Not At All	OG00017
Several Days	OG0000
More Than Half The Days	OG0000
Nearly Every Day	OG0000

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless

- ParticipantsOG00017

Title	Measurements
Not At All	OG00016
Several Days	OG0001
More Than Half The Days

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep

- ParticipantsOG00017

Title	Measurements
Not At All	OG00017
Several Days	OG0000
More Than Half The Days

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy

- ParticipantsOG00017

Title	Measurements
Not At All	OG00016
Several Days	OG0001
More Than Half The Days

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating

- ParticipantsOG00017

Title	Measurements
Not At All	OG00016
Several Days	OG0001
More Than Half The Days

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself

- ParticipantsOG00017

Title	Measurements
Not At All	OG00016
Several Days	OG0001
More Than Half The Days

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things

- ParticipantsOG00017

Title	Measurements
Not At All	OG00017
Several Days	OG0000
More Than Half The Days

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless

- ParticipantsOG00017

Title	Measurements
Not At All	OG00017
Several Days	OG0000
More Than Half The Days

Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead

- ParticipantsOG00017

Title	Measurements
Not At All	OG00017
Several Days	OG0000
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating

- ParticipantsOG00016

Title	Measurements
Not At All	OG00013
Several Days	OG0001
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy

- ParticipantsOG00016

Title	Measurements
Not At All	OG00015
Several Days	OG0001
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating

- ParticipantsOG00016

Title	Measurements
Not At All	OG00013
Several Days	OG0003
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead

- ParticipantsOG00016

Title	Measurements
Not At All	OG00016
Several Days	OG0000
More Than Half The Days

Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things

- ParticipantsOG00015

Title	Measurements
Not At All	OG00013
Several Days	OG0001
More Than Half The Days

Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless

- ParticipantsOG00015

Title	Measurements
Not At All	OG00015
Several Days	OG0000
More Than Half The Days

Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep

- ParticipantsOG00015

Title	Measurements
Not At All	OG00014
Several Days	OG0000
More Than Half The Days

Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy

- ParticipantsOG00015

Title	Measurements
Not At All	OG00013
Several Days	OG0001
More Than Half The Days

Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating

- ParticipantsOG00015

Title	Measurements
Not At All	OG00010
Several Days	OG0000
More Than Half The Days

Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself

- ParticipantsOG00015

Title	Measurements
Not At All	OG00015
Several Days	OG0000
More Than Half The Days

Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things

- ParticipantsOG00015

Title	Measurements
Not At All	OG00014
Several Days	OG0001
More Than Half The Days

Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless

- ParticipantsOG00015

Title	Measurements
Not At All	OG00014
Several Days	OG0000
More Than Half The Days

Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead

- ParticipantsOG00015

Title	Measurements
Not At All	OG00015
Several Days	OG0000
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things

- ParticipantsOG00012

Title	Measurements
Not At All	OG00011
Several Days	OG0001
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless

- ParticipantsOG00012

Title	Measurements
Not At All	OG00012
Several Days	OG0000
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep

- ParticipantsOG00012

Title	Measurements
Not At All	OG00012
Several Days	OG0000
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy

- ParticipantsOG00012

Title	Measurements
Not At All	OG00010
Several Days	OG0002
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating

- ParticipantsOG00012

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself

- ParticipantsOG00012

Title	Measurements
Not At All	OG00012
Several Days	OG0000
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things

- ParticipantsOG00012

Title	Measurements
Not At All	OG00012
Several Days	OG0000
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless

- ParticipantsOG00012

Title	Measurements
Not At All	OG00012
Several Days	OG0000
More Than Half The Days

Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead

- ParticipantsOG00012

Title	Measurements
Not At All	OG00012
Several Days	OG0000
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep

- ParticipantsOG00011

Title	Measurements
Not At All	OG00010
Several Days	OG0001
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy

- ParticipantsOG00011

Title	Measurements
Not At All	OG00010
Several Days	OG0001
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating

- ParticipantsOG00011

Title	Measurements
Not At All	OG0008
Several Days	OG0001
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things

- ParticipantsOG00011

Title	Measurements
Not At All	OG00010
Several Days	OG0001
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless

- ParticipantsOG00011

Title	Measurements
Not At All	OG00010
Several Days	OG0001
More Than Half The Days

Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things

- ParticipantsOG0009

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless

- ParticipantsOG0009

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep

- ParticipantsOG0009

Title	Measurements
Not At All	OG0008
Several Days	OG0001
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy

- ParticipantsOG0009

Title	Measurements
Not At All	OG0008
Several Days	OG0000
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating

- ParticipantsOG0009

Title	Measurements
Not At All	OG0007
Several Days	OG0000
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself

- ParticipantsOG0009

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things

- ParticipantsOG0009

Title	Measurements
Not At All	OG0008
Several Days	OG0000
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless

- ParticipantsOG0009

Title	Measurements
Not At All	OG0008
Several Days	OG0000
More Than Half The Days

Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead

- ParticipantsOG0009

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things

- ParticipantsOG0009

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless

- ParticipantsOG0009

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep

- ParticipantsOG0009

Title	Measurements
Not At All	OG0008
Several Days	OG0000
More Than Half The Days

Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy

- ParticipantsOG0009

Title	Measurements
Not At All	OG0008
Several Days	OG0000
More Than Half The Days

Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating

- ParticipantsOG0009

Title	Measurements
Not At All	OG0007
Several Days	OG0000
More Than Half The Days

Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself

- ParticipantsOG0009

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things

- ParticipantsOG0009

Title	Measurements
Not At All	OG0008
Several Days	OG0000
More Than Half The Days

Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless

- ParticipantsOG0009

Title	Measurements
Not At All	OG0008
Several Days	OG0000
More Than Half The Days

Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead

- ParticipantsOG0009

Title	Measurements
Not At All	OG0009
Several Days	OG0000
More Than Half The Days

Follow Up / Little Interest/Pleasure in Things

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Follow Up / Feeling Down Depressed or Hopeless

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Follow Up / Trouble Falling or Staying Asleep

- ParticipantsOG00011

Title	Measurements
Not At All	OG00010
Several Days	OG0001
More Than Half The Days

Follow Up / Feeling Tired or Little Energy

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Follow Up / Poor Appetite or Overeating

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Follow Up / Feeling Bad About Yourself

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Follow Up / Trouble Concentrating on Things

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Follow Up / Moving Slowly or Fidgety/Restless

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

Follow Up / Thoughts You Be Better Off Dead

- ParticipantsOG00011

Title	Measurements
Not At All	OG00011
Several Days	OG0000
More Than Half The Days

ID	Term
C000731016	danuglipron
D000069059	Atorvastatin
D008874	Midazolam
D019304	Ethinyl Estradiol-Norgestrel Combination

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D004997	Ethinyl Estradiol
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D009644	Norgestrel
D009652	Norpregnenes
D042782	Estrogenic Steroids, Alkylated
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description
BG000	All Participants in Part A	Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: atorvastatin 20mg single dose (SD) on Day 1; Period 2: midazolam 5mg SD on Day 1; Period 3: PF-06882961 10mg twice daily (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 4: PF-06882961 120mg BID+atorvastatin SD on Day 1, PF-06882961 120mg on Days 2-3; Period 5: PF-06882961 120 mg BID+ midazolam SD on Day 1; Period 6: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 7: PF-06882961 200 mg BID+atorvastatin SD on Day 1, PF-06882961 200 mg BID on Days 2-3; Part 8: PF-06882961 200 mg BID+ midazolam SD on Day 1.
BG001	All Participants in Part B	Participants underwent Period 1 to 5 and received study interventions as follows: Period 1: oral contraceptive (OC) SD on Day 1; Period 2:PF-06882961 10mg BID on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 3: PF-06882961 120mg BID+OC SD on Day 1, PF-06882961 120mg on Days 2-5; Period 4: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 5: PF-06882961 200 mg BID+OC SD on Day 1, PF-06882961 200 mg BID on Days 2-5.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Atorvastatin 20 mg (Part A Period 1)	Participants received single dose of atorvastatin 20 mg orally on Day 1 of Period 1 in Part A.	18	18	2	18
EG001	Midazolam 5 mg (Part A Period 2)	Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.	18	18	3	18
EG002	PF-06882961 Titration up to 120 mg BID (Part A Period 3)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 3 in Part A.	17	17	13	17
EG003	PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)	Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4 in Part A.	13	13	5	13
EG004	PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)	Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.	13	13	4	13
EG005	PF-06882961 Titration up to 200 mg BID (Part A Period 6)	Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.	13	13	12	13
EG006	PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)	Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.	5	5	5	5
EG007	PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)	Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.	6	6	2	6
EG008	0.15 mg LE & 0.03 mg EE (Part B Period 1)	Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.	17	17	5	17
EG009	PF-06882961 Titration up to 120 mg BID (Part B Period 2)	Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B.	16	16	15	16
EG010	PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)	Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.	14	14	7	14
EG011	PF-06882961 Titration up to 200 mg BID (Part B Period 4)	Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 4 in Part B.	12	12	12	12
EG012	PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)	Participants received PF-06882961 200 mg BID + oral contraceptive SD on Day 1 and PF-06882961 200 mg BID on Days 2-5 of Period 5 in Part B.	9	9	7	9