Trial Outcomes & Findings for Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes (NCT NCT01285518)

NCT ID: NCT01285518

Last Updated: 2016-11-18

Results Overview

Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 84 participants
• Primary outcome timeframe: Day -1 up to Day 22
• Results posted on: 2016-11-18

Participant Flow

Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM), diagnosed according to the American Diabetes Association (ADA) guidelines and those with well-controlled diabetes were recruited in the study.

Dose of PF-05231023 was escalated based on sponsor's and investigator's discretion, depending upon safety, tolerability and pharmacokinetic profile of PF-05231023.

Participant milestones

Measure	PF-05231023 0.5 mg Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Overall Study STARTED	10	10	10	10	10	10	10	14
Overall Study COMPLETED	10	10	10	10	10	9	10	14
Overall Study NOT COMPLETED	0	0	0	0	0	1	0	0

Reasons for withdrawal

Measure	PF-05231023 0.5 mg Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Overall Study Lost to Follow-up	0	0	0	0	0	1	0	0

Baseline Characteristics

Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.	Total n=84 Participants Total of all reporting groups
Age, Continuous	59.4 years STANDARD_DEVIATION 4.1 • n=5 Participants	58.4 years STANDARD_DEVIATION 3.9 • n=7 Participants	53.8 years STANDARD_DEVIATION 7.2 • n=5 Participants	53.3 years STANDARD_DEVIATION 8.2 • n=4 Participants	54.5 years STANDARD_DEVIATION 8.6 • n=21 Participants	55.2 years STANDARD_DEVIATION 7.3 • n=10 Participants	57.2 years STANDARD_DEVIATION 5.7 • n=115 Participants	52.9 years STANDARD_DEVIATION 6.8 • n=24 Participants	55.5 years STANDARD_DEVIATION 6.8 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	5 Participants n=24 Participants	24 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=10 Participants	7 Participants n=115 Participants	9 Participants n=24 Participants	60 Participants n=42 Participants

PRIMARY outcome

Timeframe: Day -1 up to Day 22

Population: Data was not collected since this outcome measure was not analyzed as per Sponsor's discretion.

Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 up to Day 22

Population: Safety population included all participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	4 participants	3 participants	3 participants	2 participants	7 participants	2 participants	8 participants	5 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day -1 up to Day 15

Population: Safety population included all participants who received at least 1 dose of study medication.

Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities was reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Abnormal Laboratory Values	9 participants	9 participants	9 participants	8 participants	10 participants	6 participants	6 participants	14 participants

PRIMARY outcome

Timeframe: Day 1 up to Day 15

Population: Safety population included all participants who received at least 1 dose of study medication.

Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Vital Signs Abnormalities Supine SBP <90 mmHg	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With Vital Signs Abnormalities Supine DBP <50 mmHg	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Vital Signs Abnormalities Supine pulse rate <40 bpm	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Vital Signs Abnormalities Supine pulse rate >120 bpm	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With Vital Signs Abnormalities Supine SBP: Maximum increase >=30 mmHg	2 participants	1 participants	0 participants	0 participants	0 participants	1 participants	2 participants	0 participants
Number of Participants With Vital Signs Abnormalities Supine DBP: Maximum increase >=20 mmHg	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With Vital Signs Abnormalities Supine SBP: Maximum decrease >=30 mmHg	1 participants	0 participants	0 participants	2 participants	1 participants	2 participants	0 participants	1 participants
Number of Participants With Vital Signs Abnormalities Supine DBP: Maximum decrease >=20 mmHg	0 participants	0 participants	2 participants	0 participants	1 participants	1 participants	0 participants	1 participants

PRIMARY outcome

Timeframe: Screening up to Day 15

Population: Safety population included all participants who received at least 1 dose of study medication.

Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec for PR interval and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Electrocardiogram (ECG) Abnormalities QTCF interval increase from baseline >=60 msec	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum PR interval >=300 msec	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QRS Complex >=140 msec	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTCF interval 450 to <480 msec	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTCF interval 480 to <500 msec	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTCF interval >=500 msec	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities PR interval increase from baseline >=25/50%	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QRS complex increase from baseline >=50%	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTCF interval increase from baseline 30 to 60 msec	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day 0 up to Day 22

Population: Safety population included all participants who received at least 1 dose of study medication.

Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose <50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration <=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration <=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration <=70 mg/dL).

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels Severe Hypoglycemia	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels Documented Symptomatic Hypoglycemia	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels Asymptomatic Hypoglycemia	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels Probable Symptomatic Hypoglycemia	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day -1 up to Day 15

Population: Safety population included all participants who received at least 1 dose of study medication.

Criteria for blood glucose abnormality: Blood glucose levels <0.6*lower limit of normal (LLN) or >1.5*upper limit of normal (ULN).

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Blood Glucose Abnormalities <0.6*LLN	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Blood Glucose Abnormalities >1.5*ULN	7 participants	6 participants	6 participants	6 participants	6 participants	5 participants	3 participants	9 participants

PRIMARY outcome

Timeframe: Day 1

Population: Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.

Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Anti-Drug Antibodies (ADA): Day 1	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: Day 8

Population: Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.

Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Anti-Drug Antibodies (ADA): Day 8	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: Day 15

Population: Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=9 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Anti-Drug Antibodies (ADA): Day 15	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—

PRIMARY outcome

Timeframe: Day 22

Population: Safety population included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=9 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=9 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=1 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Anti-Drug Antibodies (ADA): Day 22	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day 34

Population: Safety population. No participant was involved in groups: PF-05231023 0.5,1.5,5,15,50,100 mg and placebo for this time point of outcome measure, hence results were not reported for the same.'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.

Outcome measures

Measure	PF-05231023 0.5 mg n=1 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Number of Participants With Anti-Drug Antibodies (ADA): Day 34	0 participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=5 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=9 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=12 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1 IGF-1	137.2 nanogram per milliliter (ng/mL) Standard Deviation 69.33	142.3 nanogram per milliliter (ng/mL) Standard Deviation 47.10	143.4 nanogram per milliliter (ng/mL) Standard Deviation 42.80	146.8 nanogram per milliliter (ng/mL) Standard Deviation 50.97	128.4 nanogram per milliliter (ng/mL) Standard Deviation 35.44	135.7 nanogram per milliliter (ng/mL) Standard Deviation 59.12	153.1 nanogram per milliliter (ng/mL) Standard Deviation 51.57	131.3 nanogram per milliliter (ng/mL) Standard Deviation 34.71
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1 IGFBP-1	1.83 nanogram per milliliter (ng/mL) Standard Deviation 1.414	1.02 nanogram per milliliter (ng/mL) Standard Deviation 0.525	2.63 nanogram per milliliter (ng/mL) Standard Deviation 2.954	2.81 nanogram per milliliter (ng/mL) Standard Deviation 2.454	1.20 nanogram per milliliter (ng/mL) Standard Deviation 0.995	2.23 nanogram per milliliter (ng/mL) Standard Deviation 3.138	2.88 nanogram per milliliter (ng/mL) Standard Deviation 1.724	1.69 nanogram per milliliter (ng/mL) Standard Deviation 1.292
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1 IGFBP-2	173.5 nanogram per milliliter (ng/mL) Standard Deviation 109.33	134.2 nanogram per milliliter (ng/mL) Standard Deviation 50.00	143.8 nanogram per milliliter (ng/mL) Standard Deviation 48.44	197.1 nanogram per milliliter (ng/mL) Standard Deviation 147.01	108.8 nanogram per milliliter (ng/mL) Standard Deviation 39.77	147.9 nanogram per milliliter (ng/mL) Standard Deviation 89.58	204.7 nanogram per milliliter (ng/mL) Standard Deviation 122.70	146.7 nanogram per milliliter (ng/mL) Standard Deviation 79.50
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1 GH	0.178 nanogram per milliliter (ng/mL) Standard Deviation 0.2981	0.121 nanogram per milliliter (ng/mL) Standard Deviation 0.1521	0.133 nanogram per milliliter (ng/mL) Standard Deviation 0.1629	0.222 nanogram per milliliter (ng/mL) Standard Deviation 0.2189	0.316 nanogram per milliliter (ng/mL) Standard Deviation 0.4162	0.296 nanogram per milliliter (ng/mL) Standard Deviation 0.5557	0.448 nanogram per milliliter (ng/mL) Standard Deviation 0.5928	0.079 nanogram per milliliter (ng/mL) Standard Deviation 0.0355

PRIMARY outcome

Timeframe: Day 2

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.

Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2 IGF-1	141.1 ng/mL Standard Deviation 75.35	148.0 ng/mL Standard Deviation 47.00	163.5 ng/mL Standard Deviation 50.79	152.9 ng/mL Standard Deviation 51.08	145.0 ng/mL Standard Deviation 63.28	154.9 ng/mL Standard Deviation 55.30	168.4 ng/mL Standard Deviation 58.24	135.7 ng/mL Standard Deviation 33.89
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2 IGFBP-1	2.72 ng/mL Standard Deviation 2.068	2.68 ng/mL Standard Deviation 1.570	2.37 ng/mL Standard Deviation 2.489	4.37 ng/mL Standard Deviation 4.093	2.67 ng/mL Standard Deviation 1.830	2.41 ng/mL Standard Deviation 1.711	4.49 ng/mL Standard Deviation 2.824	3.01 ng/mL Standard Deviation 2.954
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2 IGFBP-2	153.1 ng/mL Standard Deviation 80.23	130.2 ng/mL Standard Deviation 43.42	154.4 ng/mL Standard Deviation 47.72	200.7 ng/mL Standard Deviation 171.17	117.7 ng/mL Standard Deviation 41.88	174.1 ng/mL Standard Deviation 104.64	212.6 ng/mL Standard Deviation 137.72	160.1 ng/mL Standard Deviation 87.53
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2 GH	0.230 ng/mL Standard Deviation 0.3135	0.369 ng/mL Standard Deviation 0.7146	0.182 ng/mL Standard Deviation 0.2109	0.386 ng/mL Standard Deviation 0.3823	0.316 ng/mL Standard Deviation 0.3116	0.407 ng/mL Standard Deviation 0.4363	0.620 ng/mL Standard Deviation 0.4641	0.498 ng/mL Standard Deviation 0.8284

PRIMARY outcome

Timeframe: Day 3

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.

Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3 IGF-1	140.1 nanogram per millileter (ng/mL) Standard Deviation 62.82	147.5 nanogram per millileter (ng/mL) Standard Deviation 45.10	158.6 nanogram per millileter (ng/mL) Standard Deviation 46.26	164.2 nanogram per millileter (ng/mL) Standard Deviation 57.90	156.3 nanogram per millileter (ng/mL) Standard Deviation 75.73	149.8 nanogram per millileter (ng/mL) Standard Deviation 57.41	178.5 nanogram per millileter (ng/mL) Standard Deviation 53.85	137.7 nanogram per millileter (ng/mL) Standard Deviation 33.10
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3 IGFBP-1	2.30 nanogram per millileter (ng/mL) Standard Deviation 1.910	2.57 nanogram per millileter (ng/mL) Standard Deviation 1.947	2.38 nanogram per millileter (ng/mL) Standard Deviation 2.863	3.00 nanogram per millileter (ng/mL) Standard Deviation 2.682	4.27 nanogram per millileter (ng/mL) Standard Deviation 4.803	2.70 nanogram per millileter (ng/mL) Standard Deviation 3.519	3.10 nanogram per millileter (ng/mL) Standard Deviation 1.694	2.00 nanogram per millileter (ng/mL) Standard Deviation 1.393
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3 IGFBP-2	160.4 nanogram per millileter (ng/mL) Standard Deviation 106.14	135.7 nanogram per millileter (ng/mL) Standard Deviation 47.46	144.4 nanogram per millileter (ng/mL) Standard Deviation 43.00	188.2 nanogram per millileter (ng/mL) Standard Deviation 138.45	129.1 nanogram per millileter (ng/mL) Standard Deviation 42.61	155.0 nanogram per millileter (ng/mL) Standard Deviation 99.66	223.3 nanogram per millileter (ng/mL) Standard Deviation 120.05	145.2 nanogram per millileter (ng/mL) Standard Deviation 61.69
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3 GH	0.186 nanogram per millileter (ng/mL) Standard Deviation 0.2030	0.192 nanogram per millileter (ng/mL) Standard Deviation 0.1165	0.273 nanogram per millileter (ng/mL) Standard Deviation 0.3549	0.312 nanogram per millileter (ng/mL) Standard Deviation 0.3008	0.432 nanogram per millileter (ng/mL) Standard Deviation 0.6493	0.406 nanogram per millileter (ng/mL) Standard Deviation 0.3544	0.588 nanogram per millileter (ng/mL) Standard Deviation 0.4084	0.169 nanogram per millileter (ng/mL) Standard Deviation 0.1647

PRIMARY outcome

Timeframe: Day 5

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.

Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5 IGF-1	138.4 nanogram per millileter (ng/mL) Standard Deviation 74.86	156.1 nanogram per millileter (ng/mL) Standard Deviation 40.03	152.7 nanogram per millileter (ng/mL) Standard Deviation 48.18	155.4 nanogram per millileter (ng/mL) Standard Deviation 54.29	136.9 nanogram per millileter (ng/mL) Standard Deviation 54.82	143.6 nanogram per millileter (ng/mL) Standard Deviation 54.03	163.6 nanogram per millileter (ng/mL) Standard Deviation 44.96	137.0 nanogram per millileter (ng/mL) Standard Deviation 27.00
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5 IGFBP-1	2.45 nanogram per millileter (ng/mL) Standard Deviation 2.186	2.36 nanogram per millileter (ng/mL) Standard Deviation 1.629	2.61 nanogram per millileter (ng/mL) Standard Deviation 2.497	2.93 nanogram per millileter (ng/mL) Standard Deviation 2.547	4.02 nanogram per millileter (ng/mL) Standard Deviation 4.484	2.64 nanogram per millileter (ng/mL) Standard Deviation 3.102	3.11 nanogram per millileter (ng/mL) Standard Deviation 1.805	2.31 nanogram per millileter (ng/mL) Standard Deviation 2.466
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5 IGFBP-2	169.1 nanogram per millileter (ng/mL) Standard Deviation 101.02	129.4 nanogram per millileter (ng/mL) Standard Deviation 44.14	152.4 nanogram per millileter (ng/mL) Standard Deviation 61.19	193.1 nanogram per millileter (ng/mL) Standard Deviation 137.11	135.5 nanogram per millileter (ng/mL) Standard Deviation 43.32	156.1 nanogram per millileter (ng/mL) Standard Deviation 117.61	207.9 nanogram per millileter (ng/mL) Standard Deviation 97.73	150.1 nanogram per millileter (ng/mL) Standard Deviation 69.66
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5 GH	0.190 nanogram per millileter (ng/mL) Standard Deviation 0.2492	0.146 nanogram per millileter (ng/mL) Standard Deviation 0.0802	0.169 nanogram per millileter (ng/mL) Standard Deviation 0.1788	0.233 nanogram per millileter (ng/mL) Standard Deviation 0.1884	0.271 nanogram per millileter (ng/mL) Standard Deviation 0.3159	0.188 nanogram per millileter (ng/mL) Standard Deviation 0.1641	0.484 nanogram per millileter (ng/mL) Standard Deviation 0.4962	0.216 nanogram per millileter (ng/mL) Standard Deviation 0.2418

PRIMARY outcome

Timeframe: Day 7

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. Here,'n' signifies participants who were evaluable at each specified time point for each arm, respectively.

Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7 IGF-1 (n=10,10,10,10,10,10,10,14)	142.1 nanogram per milliliter (ng/mL) Standard Deviation 73.55	151.0 nanogram per milliliter (ng/mL) Standard Deviation 47.72	152.3 nanogram per milliliter (ng/mL) Standard Deviation 54.13	157.1 nanogram per milliliter (ng/mL) Standard Deviation 61.32	130.4 nanogram per milliliter (ng/mL) Standard Deviation 55.44	143.9 nanogram per milliliter (ng/mL) Standard Deviation 59.06	154.1 nanogram per milliliter (ng/mL) Standard Deviation 41.88	132.5 nanogram per milliliter (ng/mL) Standard Deviation 28.07
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7 IGFBP-1 (n=10,10,10,10,10,9,10,14)	4.67 nanogram per milliliter (ng/mL) Standard Deviation 3.533	2.77 nanogram per milliliter (ng/mL) Standard Deviation 2.113	3.03 nanogram per milliliter (ng/mL) Standard Deviation 3.261	2.98 nanogram per milliliter (ng/mL) Standard Deviation 3.948	2.61 nanogram per milliliter (ng/mL) Standard Deviation 2.348	2.80 nanogram per milliliter (ng/mL) Standard Deviation 3.440	3.39 nanogram per milliliter (ng/mL) Standard Deviation 1.824	3.46 nanogram per milliliter (ng/mL) Standard Deviation 4.404
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7 IGFBP-2 (n=10,10,10,10,10,9,10,14)	187.7 nanogram per milliliter (ng/mL) Standard Deviation 107.34	116.5 nanogram per milliliter (ng/mL) Standard Deviation 30.62	166.4 nanogram per milliliter (ng/mL) Standard Deviation 48.32	178.7 nanogram per milliliter (ng/mL) Standard Deviation 126.83	132.8 nanogram per milliliter (ng/mL) Standard Deviation 46.18	173.8 nanogram per milliliter (ng/mL) Standard Deviation 148.78	229.8 nanogram per milliliter (ng/mL) Standard Deviation 118.94	154.7 nanogram per milliliter (ng/mL) Standard Deviation 88.03
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7 GH (n=10,10,10,10,10,10,10,14)	0.233 nanogram per milliliter (ng/mL) Standard Deviation 0.2506	0.112 nanogram per milliliter (ng/mL) Standard Deviation 0.0738	0.108 nanogram per milliliter (ng/mL) Standard Deviation 0.0760	0.254 nanogram per milliliter (ng/mL) Standard Deviation 0.3971	0.142 nanogram per milliliter (ng/mL) Standard Deviation 0.1003	0.120 nanogram per milliliter (ng/mL) Standard Deviation 0.1067	0.320 nanogram per milliliter (ng/mL) Standard Deviation 0.1942	0.201 nanogram per milliliter (ng/mL) Standard Deviation 0.2193

PRIMARY outcome

Timeframe: Day 15

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.

Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=9 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=9 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=9 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15 IGF-1 (n=10,10,9,10,10,9,9,14)	117.7 nanogram per milliliter (ng/mL) Standard Deviation 55.26	132.6 nanogram per milliliter (ng/mL) Standard Deviation 42.72	116.7 nanogram per milliliter (ng/mL) Standard Deviation 38.99	131.2 nanogram per milliliter (ng/mL) Standard Deviation 45.53	106.2 nanogram per milliliter (ng/mL) Standard Deviation 44.50	123.2 nanogram per milliliter (ng/mL) Standard Deviation 51.08	126.3 nanogram per milliliter (ng/mL) Standard Deviation 40.32	112.5 nanogram per milliliter (ng/mL) Standard Deviation 25.85
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15 IGFBP-1 (n=10,10,9,10,10,9,9,14)	3.30 nanogram per milliliter (ng/mL) Standard Deviation 1.999	2.59 nanogram per milliliter (ng/mL) Standard Deviation 1.573	2.90 nanogram per milliliter (ng/mL) Standard Deviation 3.357	2.28 nanogram per milliliter (ng/mL) Standard Deviation 2.262	2.70 nanogram per milliliter (ng/mL) Standard Deviation 2.186	3.23 nanogram per milliliter (ng/mL) Standard Deviation 3.567	3.36 nanogram per milliliter (ng/mL) Standard Deviation 2.261	2.11 nanogram per milliliter (ng/mL) Standard Deviation 1.690
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15 IGFBP-2 (n=10,10,9,10,10,9,9,14)	215.6 nanogram per milliliter (ng/mL) Standard Deviation 89.55	154.7 nanogram per milliliter (ng/mL) Standard Deviation 38.39	157.3 nanogram per milliliter (ng/mL) Standard Deviation 60.35	240.8 nanogram per milliliter (ng/mL) Standard Deviation 177.76	155.4 nanogram per milliliter (ng/mL) Standard Deviation 49.16	193.1 nanogram per milliliter (ng/mL) Standard Deviation 145.98	247.3 nanogram per milliliter (ng/mL) Standard Deviation 145.61	181.6 nanogram per milliliter (ng/mL) Standard Deviation 129.74
Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15 GH (n=10,10,9,10,10,9,9,14)	0.216 nanogram per milliliter (ng/mL) Standard Deviation 0.2557	0.135 nanogram per milliliter (ng/mL) Standard Deviation 0.1039	0.133 nanogram per milliliter (ng/mL) Standard Deviation 0.1111	0.115 nanogram per milliliter (ng/mL) Standard Deviation 0.0920	0.090 nanogram per milliliter (ng/mL) Standard Deviation 0.0927	0.161 nanogram per milliliter (ng/mL) Standard Deviation 0.1388	0.183 nanogram per milliliter (ng/mL) Standard Deviation 0.2236	0.180 nanogram per milliliter (ng/mL) Standard Deviation 0.1628

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=5 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=9 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=12 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1	3.09 microgram per milliliter (mcg/mL) Standard Deviation 1.028	4.03 microgram per milliliter (mcg/mL) Standard Deviation 1.325	3.80 microgram per milliliter (mcg/mL) Standard Deviation 1.026	3.47 microgram per milliliter (mcg/mL) Standard Deviation 0.804	3.52 microgram per milliliter (mcg/mL) Standard Deviation 1.260	3.44 microgram per milliliter (mcg/mL) Standard Deviation 1.198	3.52 microgram per milliliter (mcg/mL) Standard Deviation 1.003	3.66 microgram per milliliter (mcg/mL) Standard Deviation 0.925

PRIMARY outcome

Timeframe: Day 2

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.

Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2	3.11 mcg/mL Standard Deviation 0.983	4.04 mcg/mL Standard Deviation 1.211	3.78 mcg/mL Standard Deviation 0.887	3.49 mcg/mL Standard Deviation 0.839	3.79 mcg/mL Standard Deviation 1.440	3.53 mcg/mL Standard Deviation 1.069	3.53 mcg/mL Standard Deviation 0.888	3.63 mcg/mL Standard Deviation 0.986

PRIMARY outcome

Timeframe: Day 3

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.

Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3	3.14 mcg/mL Standard Deviation 0.964	3.99 mcg/mL Standard Deviation 1.180	3.82 mcg/mL Standard Deviation 0.957	3.56 mcg/mL Standard Deviation 0.957	3.69 mcg/mL Standard Deviation 1.433	3.38 mcg/mL Standard Deviation 0.907	3.54 mcg/mL Standard Deviation 0.948	3.75 mcg/mL Standard Deviation 0.924

PRIMARY outcome

Timeframe: Day 5

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.

Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5	3.12 mcg/mL Standard Deviation 0.930	3.98 mcg/mL Standard Deviation 1.269	3.89 mcg/mL Standard Deviation 1.026	3.53 mcg/mL Standard Deviation 0.830	3.41 mcg/mL Standard Deviation 1.242	3.27 mcg/mL Standard Deviation 1.024	3.32 mcg/mL Standard Deviation 0.747	3.60 mcg/mL Standard Deviation 0.969

PRIMARY outcome

Timeframe: Day 7

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.

Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7	3.27 mcg/mL Standard Deviation 1.049	4.01 mcg/mL Standard Deviation 1.297	3.84 mcg/mL Standard Deviation 0.969	3.58 mcg/mL Standard Deviation 0.968	3.43 mcg/mL Standard Deviation 1.378	3.25 mcg/mL Standard Deviation 0.996	3.32 mcg/mL Standard Deviation 0.721	3.51 mcg/mL Standard Deviation 0.901

PRIMARY outcome

Timeframe: Day 15

Population: Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=9 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=9 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=9 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 Participants Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15	2.88 mcg/mL Standard Deviation 0.884	3.72 mcg/mL Standard Deviation 1.166	3.51 mcg/mL Standard Deviation 0.961	3.25 mcg/mL Standard Deviation 0.654	3.11 mcg/mL Standard Deviation 1.135	3.30 mcg/mL Standard Deviation 0.890	3.20 mcg/mL Standard Deviation 0.876	3.46 mcg/mL Standard Deviation 0.920

PRIMARY outcome

Timeframe: From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1

Population: Data was not collected since this outcome measure was not analyzed as per Sponsor's discretion.

Criteria for abnormal cardiac rhythms was based on investigator's discretion and were reported as adverse event (AE), as planned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Population: Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

Participants who received PF-05231023 with C-terminal and N-terminal AUClast were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023 C-terminal	672.3 ng*hour[H]/mL Standard Deviation 364.50	2573 ng*hour[H]/mL Standard Deviation 475.73	10220 ng*hour[H]/mL Standard Deviation 4059.2	29390 ng*hour[H]/mL Standard Deviation 6697.4	95120 ng*hour[H]/mL Standard Deviation 13749	244200 ng*hour[H]/mL Standard Deviation 83895	409300 ng*hour[H]/mL Standard Deviation 135030	—
Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023 N-terminal	2957 ng*hour[H]/mL Standard Deviation 1887.2	11630 ng*hour[H]/mL Standard Deviation 4363.6	47650 ng*hour[H]/mL Standard Deviation 10833	168600 ng*hour[H]/mL Standard Deviation 50175	564600 ng*hour[H]/mL Standard Deviation 161560	121100 ng*hour[H]/mL Standard Deviation 386970	280000 ng*hour[H]/mL Standard Deviation 756220	—

SECONDARY outcome

Timeframe: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Population: PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.

Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 C-terminal	0.250 hour Interval 0.25 to 0.533	0.250 hour Interval 0.25 to 0.5	1.50 hour Interval 1.5 to 3.0	1.50 hour Interval 1.02 to 2.53	1.26 hour Interval 1.0 to 1.5	1.50 hour Interval 1.0 to 6.0	1.02 hour Interval 1.0 to 2.5	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 N-terminal	0.250 hour Interval 0.25 to 3.03	0.250 hour Interval 0.25 to 1.0	1.50 hour Interval 1.5 to 6.0	1.50 hour Interval 1.02 to 2.5	1.26 hour Interval 1.0 to 6.0	1.50 hour Interval 1.0 to 2.5	1.50 hour Interval 1.0 to 2.52	—

SECONDARY outcome

Timeframe: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Population: PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.

Participants who received PF-05231023 with C-terminal and N-terminal Cmax were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 C-terminal	110.7 ng/mL Standard Deviation 40.994	347.9 ng/mL Standard Deviation 61.165	1360 ng/mL Standard Deviation 1264.9	3324 ng/mL Standard Deviation 656.74	11730 ng/mL Standard Deviation 4857.6	28740 ng/mL Standard Deviation 8031.1	47780 ng/mL Standard Deviation 13784	—
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 N-terminal	121.0 ng/mL Standard Deviation 44.923	393.2 ng/mL Standard Deviation 75.603	1199 ng/mL Standard Deviation 386.56	3693 ng/mL Standard Deviation 714.42	14180 ng/mL Standard Deviation 3928.7	28850 ng/mL Standard Deviation 6375.5	61910 ng/mL Standard Deviation 8125.5	—

SECONDARY outcome

Timeframe: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Population: PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.

Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=7 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=9 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Plasma Terminal Half-Life (t1/2) of PF-05231023 C-terminal (n=2,10,10,9,10,10,10)	NA hour Standard Deviation NA Data was not reported since less than 3 participants were evaluable.	6.504 hour Standard Deviation 1.0814	7.168 hour Standard Deviation 1.2433	7.143 hour Standard Deviation 1.5009	7.748 hour Standard Deviation 1.1304	7.502 hour Standard Deviation 0.9999	7.302 hour Standard Deviation 1.7117	—
Plasma Terminal Half-Life (t1/2) of PF-05231023 N-terminal (n=7,9,10,10,9,10,10)	31.49 hour Standard Deviation 6.5685	37.64 hour Standard Deviation 9.0438	66.54 hour Standard Deviation 12.792	77.39 hour Standard Deviation 11.979	81.52 hour Standard Deviation 12.599	87.69 hour Standard Deviation 16.556	96.64 hour Standard Deviation 8.0925	—

SECONDARY outcome

Timeframe: Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Population: PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.Participants who received PF-05231023 with C-terminal and N-terminal CL were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=7 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=9 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing C-terminal (n=2,10,10,9,10,10,10)	NA liter per hour Standard Deviation NA Data was not reported since less than 3 participants were evaluable.	0.5368 liter per hour Standard Deviation 0.0972	0.4642 liter per hour Standard Deviation 0.15736	0.4974 liter per hour Standard Deviation 0.12295	0.5245 liter per hour Standard Deviation 0.0892	0.4092 liter per hour Standard Deviation 0.12015	0.4883 liter per hour Standard Deviation 0.25652	—
Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing N-terminal (n=7,9,10,10,9,10,10)	0.1057 liter per hour Standard Deviation 0.0459	0.1282 liter per hour Standard Deviation 0.0417	0.1014 liter per hour Standard Deviation 0.0203	0.0879 liter per hour Standard Deviation 0.03216	0.08611 liter per hour Standard Deviation 0.02916	0.08050 liter per hour Standard Deviation 0.0256	0.07021 liter per hour Standard Deviation 0.0186	—

SECONDARY outcome

Timeframe: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Population: PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PF-05231023 with C-terminal and N-terminal Vz were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=7 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=9 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Apparent Volume of Distribution (Vz) of PF-05231023 C-terminal (n=2,10,10,9,10,10,10 )	NA Liter Standard Deviation NA Data was not reported since less than 3 participants were evaluable.	4.977 Liter Standard Deviation 0.93206	4.741 Liter Standard Deviation 1.1834	5.029 Liter Standard Deviation 0.81502	5.799 Liter Standard Deviation 1.5559	4.397 Liter Standard Deviation 1.1511	5.014 Liter Standard Deviation 1.2498	—
Apparent Volume of Distribution (Vz) of PF-05231023 N-terminal (n=7,9,10,10,9,10,10)	4.709 Liter Standard Deviation 0.82966	6.758 Liter Standard Deviation 1.1934	9.526 Liter Standard Deviation 2.2753	9.704 Liter Standard Deviation 2.1259	10.01 Liter Standard Deviation 2.9519	9.979 Liter Standard Deviation 2.7792	9.767 Liter Standard Deviation 2.5208	—

SECONDARY outcome

Timeframe: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Population: PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). PF-05231023 with C-terminal and N-terminal AUC (0 - ∞) were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=7 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=9 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023 C-terminal (n=2,10,10,9,10,10,10)	NA ng*hr/ml Standard Deviation NA Data was not reported since less than 3 participants were evaluable.	2793 ng*hr/ml Standard Deviation 557.86	10770 ng*hr/ml Standard Deviation 3999.8	30140 ng*hr/ml Standard Deviation 7079.3	95350 ng*hr/ml Standard Deviation 13817	244300 ng*hr/ml Standard Deviation 84238	409700 ng*hr/ml Standard Deviation 135300	—
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023 N-terminal (n=7,9,10,10,9,10,10)	4726 ng*hr/ml Standard Deviation 1594.5	11700 ng*hr/ml Standard Deviation 4305.5	49340 ng*hr/ml Standard Deviation 10835	170600 ng*hr/ml Standard Deviation 50735	581000 ng*hr/ml Standard Deviation 168820	1241000 ng*hr/ml Standard Deviation 395290	2848000 ng*hr/ml Standard Deviation 779810	—

SECONDARY outcome

Timeframe: 0.25 H post-dose to Bo on Day 1

Population: PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. C0 was calculated for cohort 1 (group: PF-05231023 0.5 mg) and 2 (group: PF-05231023 1.5 mg) only as per planned analysis, hence results for the same reported.

C0 was estimated by back-extrapolating from the first 2 concentration values using the log-linear regression on the first 2 data points (where second concentration was less than [<] first concentration) to back-extrapolate C0. PF-05231023 with C-terminal and N-terminal C0 were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=10 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Back-extrapolated Concentration at Time Zero (C0) of PF-05231023 C-terminal	116.7 ng/mL Standard Deviation 47.581	363.0 ng/mL Standard Deviation 81.903	—	—	—	—	—	—
Back-extrapolated Concentration at Time Zero (C0) of PF-05231023 N-terminal	131.8 ng/mL Standard Deviation 47.543	415.4 ng/mL Standard Deviation 81.456	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22

Population: PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.

Vss was calculated by dividing the area under the first moment curve from time zero to infinity [AUMC(0-∞)] with the product of area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] and apparent clearance (CL). PF-05231023 with C-terminal and N-terminal Vss were reported.

Outcome measures

Measure	PF-05231023 0.5 mg n=7 Participants Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 Participants Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 Participants Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=9 Participants Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 Participants Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 Participants Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 Participants Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Volume of Distribution at Steady State (Vss) of PF-05231023 C-terminal (n=2,10,10,9,10,10,10)	NA L Standard Deviation NA Data was not reported since less than 3 participants were evaluable.	4.897 L Standard Deviation 0.9277	4.596 L Standard Deviation 1.2589	5.023 L Standard Deviation 0.96722	5.650 L Standard Deviation 1.9178	4.082 L Standard Deviation 1.1896	4.655 L Standard Deviation 1.0748	—
Volume of Distribution at Steady State (Vss) of PF-05231023 N-terminal (n=7,9,10,10,9,10,10)	4.544 L Standard Deviation 0.81713	6.151 L Standard Deviation 1.1762	7.165 L Standard Deviation 1.4032	7.322 L Standard Deviation 1.2447	7.022 L Standard Deviation 1.4714	7.004 L Standard Deviation 1.4774	7.197 L Standard Deviation 1.4347	—

Adverse Events

PF-05231023 0.5 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-05231023 1.5 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-05231023 5 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-05231023 15 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PF-05231023 50 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-05231023 100 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PF-05231023 200 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PF-05231023 0.5 mg n=10 participants at risk Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.	PF-05231023 1.5 mg n=10 participants at risk Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.	PF-05231023 5 mg n=10 participants at risk Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 15 mg n=10 participants at risk Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 50 mg n=10 participants at risk Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 100 mg n=10 participants at risk Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.	PF-05231023 200 mg n=10 participants at risk Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.	Placebo n=14 participants at risk Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 1/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tachycardia	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctivitis	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Dry eye	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vision blurred	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	20.0% 2/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	60.0% 6/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 1/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 1/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Administration site reaction	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Early satiety	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection site induration	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Increased appetite	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 1/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 1/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Migraine	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis contact	20.0% 2/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 1/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Flushing	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER