| Primary | Number of Participants With Abnormal Physical Examination Findings | Physical examination included assessment of height, weight, blood pressure, pulse rate and body temperature. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned. | Physical examination data reported in this study was for identification of adverse events and were reported as adverse event in the AE section. | Posted | | | | | | Baseline up to Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG004 | PF-05231023 140 mg | PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. |
| | | |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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 Day 77 which were absent before treatment or that worsened relative to pretreatment state. | Safety population included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 77 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. |
|
| Primary | Number of Participants With Abnormal Laboratory Values | 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></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>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></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>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 were reported. | Safety population included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. |
|
| Primary | Number of Participants With Vital Signs Abnormalities | Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mm Hg), supine diastolic BP (DBP) <50 mm Hg, supine pulse rate <40 beats per minute (bpm), > 120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mm Hg and maximum increase or decrease from baseline in supine DBP >=20 mm Hg. | Safety population included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 77 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 100 mg | |
|
| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | 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 and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% 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). | Safety population included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 77 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. |
|
| Primary | Number of Participants With Blood Glucose Abnormalities | Criteria for blood glucose abnormality: Blood glucose levels <0.6* LLN or >1.5* ULN. | Safety population included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG004 |
|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose | Participants who received PF-05231023 with C-terminal and N-terminal AUCtau were reported. | Pharmacokinetic (PK) parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | | 0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 140 mg | |
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose | Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hour | | 0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 140 mg | PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose | Participants who received PF 05231023 with C-terminal and N-terminal Cmax were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | 0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 140 mg | PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. |
|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 at Steady State | Participants who received PF-05231023 with C-terminal and N-terminal AUCtau at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | ng*hr/mL | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 140 mg |
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05231023 at Steady State | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state. Participants who received PF-05231023 with C-terminal and N-terminal AUClast at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | ng*hr/mL | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. |
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 at Steady State | Participants who received PF-05231023 with C-terminal and N-terminal Tmax at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Full Range | hour | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 140 mg |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-05231023 at Steady State | Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 140 mg |
|
| Secondary | Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval of PF-05231023 (Rac) | Rac was obtained from AUCtau at steady state (Day 25) divided by AUCtau after single dose (Day 1). AUCtau was the area under the concentration-time profile from time zero to end of dosing interval, where tau = 72 hours for Day 1 and tau = 96 hours for Day 25. Participants who received PF-05231023 with C-terminal and N-terminal Rac at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | ratio | | 0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | |
|
| Secondary | Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF- 05231023 | Accumulation ratio based on maximum plasma concentration (Cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 25) divided by Cmax at first dose (Day 1). Participants who received PF-05231023 with C-terminal and N-terminal Rac,Cmax at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | ratio | | 0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. |
|
| Secondary | Plasma Terminal Half-Life (t1/2) of PF-05231023 at Steady State | 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 at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. "n" signifies those participants who were evaluated for this measure at the specified terminal for each arm. | Posted | | Mean | Standard Deviation | hour | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 |
|
| Secondary | Apparent Clearance (CL) of PF-05231023 at Steady State | 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 at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | liter per hour | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 |
|
| Secondary | Volume of Distribution of PF-05231023 at Steady State (Vss) | 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. Vss is the apparent volume of distribution at steady-state. PF-05231023 with C-terminal and N-terminal Vss at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. "n" signifies those participants who were evaluated for this measure at the specified terminal for each arm. | Posted | | Geometric Mean | Standard Deviation | liter | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. |
|
| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 at Steady State | Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 140 mg |
|
| Secondary | Average Plasma Concentration (Cav) of PF-05231023 at Steady State | Participants who received PF-05231023 with C-terminal and N-terminal Cmax at steady state were reported. | PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29 | | | | ID | Title | Description |
|---|
| OG000 | PF-05231023 5 mg | PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG001 | PF-05231023 25 mg | PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25. | | OG002 | PF-05231023 100 mg | PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25. | | OG003 | PF-05231023 140 mg |
|