Trial Outcomes & Findings for Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD) (NCT NCT03248882)
NCT ID: NCT03248882
Last Updated: 2020-12-09
Results Overview
MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2\* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
305 participants
Primary outcome timeframe
Baseline (between Day -14 and Day 1), Week 16
Results posted on
2020-12-09
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
63
|
62
|
58
|
61
|
|
Overall Study
Received Treatment
|
61
|
63
|
62
|
58
|
61
|
|
Overall Study
COMPLETED
|
54
|
58
|
55
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
7
|
10
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
2
|
6
|
9
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
4
|
2
|
Baseline Characteristics
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Baseline characteristics by cohort
| Measure |
Placebo
n=61 Participants
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=63 Participants
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=62 Participants
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=58 Participants
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=61 Participants
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
54.1 Years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
52.7 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
54.0 Years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
52.8 Years
STANDARD_DEVIATION 13.1 • n=21 Participants
|
53.38 Years
STANDARD_DEVIATION 11.99 • n=8 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
171 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
134 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
252 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline (between Day -14 and Day 1), Week 16Population: All randomized participants who received at least 1 dose of randomized study treatment and with non-missing baseline and post-baseline endpoint.
MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2\* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.
Outcome measures
| Measure |
Placebo
n=55 Participants
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=59 Participants
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=57 Participants
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=54 Participants
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=51 Participants
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
|
-7.2 Percent change
Interval -13.9 to 0.0
|
-17.1 Percent change
Interval -22.7 to -11.1
|
-49.9 Percent change
Interval -53.3 to -46.2
|
-55.9 Percent change
Interval -59.0 to -52.4
|
-64.8 Percent change
Interval -67.5 to -62.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Week 16Population: All randomized participants who received at least 1 dose of randomized study treatment and diagnosed/presumed with nonalcoholic steatohepatitis.
Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)
Outcome measures
| Measure |
Placebo
n=40 Participants
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=42 Participants
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=42 Participants
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=39 Participants
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=40 Participants
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Alanine Aminotransferase at Week 16
|
-8.5 Percent change
Interval -15.2 to -1.2
|
-12.5 Percent change
Interval -18.7 to -5.8
|
-27.7 Percent change
Interval -32.9 to -22.2
|
-31.3 Percent change
Interval -36.6 to -25.5
|
-46.8 Percent change
Interval -50.8 to -42.4
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to Week 20Population: All randomized participants who received at least 1 dose of randomized study treatment.
An AE was any untoward medical occurrence in a study subject administered a product or medical device. A serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Outcome measures
| Measure |
Placebo
n=61 Participants
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=63 Participants
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=62 Participants
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=58 Participants
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=61 Participants
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
All-causality AE
|
41 Participants
|
40 Participants
|
42 Participants
|
45 Participants
|
40 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
All-causality SAE
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Treatment-related AE
|
16 Participants
|
9 Participants
|
12 Participants
|
16 Participants
|
23 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Treatment-related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to Week 20Population: All randomized participants who received at least 1 dose of randomized study treatment and had laboratory data.
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).
Outcome measures
| Measure |
Placebo
n=59 Participants
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=63 Participants
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=62 Participants
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=58 Participants
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=61 Participants
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
39 Participants
|
44 Participants
|
36 Participants
|
33 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to Week 18Population: All randomized participants who received at least 1 dose of randomized study treatment and had vital signs data.
Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) \<90 or \>180 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) \<50 mmHg or \>110 mmHg; 3) sitting pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (\>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP \>=30 mmHg.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=63 Participants
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=62 Participants
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=58 Participants
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=61 Participants
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting SBP <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting SBP >180 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting SBP increase >=30 mmHg
|
5 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting SBP decrease >=30 mmHg
|
2 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting DBP <50 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting DBP >110 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting DBP increase >=20 mmHg
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting DBP decrease >=20 mmHg
|
0 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting pulse rate <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Sitting pulse rate >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to Week 18Population: All randomized participants who received at least 1 dose of randomized study treatment and had ECG data.
ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) \>=140 milliseconds (msec); 2) QRS interval \>=50% change from baseline; 3) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization) \>=300 msec; 4) PR interval \>=25% change when baseline is \>200 msec or \>=50% change when baseline is \<=200 msec; 5) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of \>=500 msec; 6) QTcF interval (QT corrected for heart rate using Fridericia's formula) absolute value of 450 to \<480 msec; 7) QTcF interval: absolute value of 480 to \<500 msec; 8) QTcF interval: absolute value \>=500 msec; 9) QTcF interval: a change from baseline of 30 to \<60 msec; 10) QTcF interval: a change from baseline \>=60 msec.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=63 Participants
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=61 Participants
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=58 Participants
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=60 Participants
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
PR interval >=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
%Change in PR interval >=25/50%
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
QRS interval >=140 msec
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
%Change in QRS interval >=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
QT interval >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
QTcF interval >=450 to <480 msec
|
6 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
QTcF interval >=480 to <500 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
QTcF interval >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
QTcF interval increase >=30 to 60 msec
|
5 Participants
|
6 Participants
|
8 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
QTcF interval increase >=60 msec
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
PF-05221304 2 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
PF-05221304 10 mg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
PF-05221304 25 mg
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
PF-05221304 50 mg
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=61 participants at risk
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=63 participants at risk
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=62 participants at risk
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=58 participants at risk
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=61 participants at risk
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
0.00%
0/62 • From first dose of study treatment up to 20 weeks
|
1.7%
1/58 • From first dose of study treatment up to 20 weeks
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
1.6%
1/63 • From first dose of study treatment up to 20 weeks
|
0.00%
0/62 • From first dose of study treatment up to 20 weeks
|
0.00%
0/58 • From first dose of study treatment up to 20 weeks
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
0.00%
0/62 • From first dose of study treatment up to 20 weeks
|
1.7%
1/58 • From first dose of study treatment up to 20 weeks
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
1.6%
1/63 • From first dose of study treatment up to 20 weeks
|
0.00%
0/62 • From first dose of study treatment up to 20 weeks
|
0.00%
0/58 • From first dose of study treatment up to 20 weeks
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
1.6%
1/62 • From first dose of study treatment up to 20 weeks
|
0.00%
0/58 • From first dose of study treatment up to 20 weeks
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
1.6%
1/62 • From first dose of study treatment up to 20 weeks
|
0.00%
0/58 • From first dose of study treatment up to 20 weeks
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
0.00%
0/62 • From first dose of study treatment up to 20 weeks
|
0.00%
0/58 • From first dose of study treatment up to 20 weeks
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
0.00%
0/62 • From first dose of study treatment up to 20 weeks
|
0.00%
0/58 • From first dose of study treatment up to 20 weeks
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
Other adverse events
| Measure |
Placebo
n=61 participants at risk
Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.
|
PF-05221304 2 mg
n=63 participants at risk
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
|
PF-05221304 10 mg
n=62 participants at risk
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.
|
PF-05221304 25 mg
n=58 participants at risk
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.
|
PF-05221304 50 mg
n=61 participants at risk
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
1.6%
1/62 • From first dose of study treatment up to 20 weeks
|
10.3%
6/58 • From first dose of study treatment up to 20 weeks
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
3/61 • From first dose of study treatment up to 20 weeks
|
4.8%
3/63 • From first dose of study treatment up to 20 weeks
|
12.9%
8/62 • From first dose of study treatment up to 20 weeks
|
3.4%
2/58 • From first dose of study treatment up to 20 weeks
|
6.6%
4/61 • From first dose of study treatment up to 20 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.9%
3/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
4.8%
3/62 • From first dose of study treatment up to 20 weeks
|
8.6%
5/58 • From first dose of study treatment up to 20 weeks
|
6.6%
4/61 • From first dose of study treatment up to 20 weeks
|
|
General disorders
Fatigue
|
8.2%
5/61 • From first dose of study treatment up to 20 weeks
|
4.8%
3/63 • From first dose of study treatment up to 20 weeks
|
3.2%
2/62 • From first dose of study treatment up to 20 weeks
|
3.4%
2/58 • From first dose of study treatment up to 20 weeks
|
3.3%
2/61 • From first dose of study treatment up to 20 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
4.8%
3/62 • From first dose of study treatment up to 20 weeks
|
5.2%
3/58 • From first dose of study treatment up to 20 weeks
|
3.3%
2/61 • From first dose of study treatment up to 20 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
2/61 • From first dose of study treatment up to 20 weeks
|
9.5%
6/63 • From first dose of study treatment up to 20 weeks
|
4.8%
3/62 • From first dose of study treatment up to 20 weeks
|
5.2%
3/58 • From first dose of study treatment up to 20 weeks
|
3.3%
2/61 • From first dose of study treatment up to 20 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
1.6%
1/63 • From first dose of study treatment up to 20 weeks
|
3.2%
2/62 • From first dose of study treatment up to 20 weeks
|
8.6%
5/58 • From first dose of study treatment up to 20 weeks
|
6.6%
4/61 • From first dose of study treatment up to 20 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
1.6%
1/62 • From first dose of study treatment up to 20 weeks
|
5.2%
3/58 • From first dose of study treatment up to 20 weeks
|
3.3%
2/61 • From first dose of study treatment up to 20 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.3%
2/61 • From first dose of study treatment up to 20 weeks
|
1.6%
1/63 • From first dose of study treatment up to 20 weeks
|
9.7%
6/62 • From first dose of study treatment up to 20 weeks
|
6.9%
4/58 • From first dose of study treatment up to 20 weeks
|
16.4%
10/61 • From first dose of study treatment up to 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
1.6%
1/63 • From first dose of study treatment up to 20 weeks
|
4.8%
3/62 • From first dose of study treatment up to 20 weeks
|
6.9%
4/58 • From first dose of study treatment up to 20 weeks
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.6%
4/61 • From first dose of study treatment up to 20 weeks
|
0.00%
0/63 • From first dose of study treatment up to 20 weeks
|
3.2%
2/62 • From first dose of study treatment up to 20 weeks
|
1.7%
1/58 • From first dose of study treatment up to 20 weeks
|
0.00%
0/61 • From first dose of study treatment up to 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
2/61 • From first dose of study treatment up to 20 weeks
|
4.8%
3/63 • From first dose of study treatment up to 20 weeks
|
6.5%
4/62 • From first dose of study treatment up to 20 weeks
|
3.4%
2/58 • From first dose of study treatment up to 20 weeks
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
|
Nervous system disorders
Dizziness
|
6.6%
4/61 • From first dose of study treatment up to 20 weeks
|
4.8%
3/63 • From first dose of study treatment up to 20 weeks
|
1.6%
1/62 • From first dose of study treatment up to 20 weeks
|
5.2%
3/58 • From first dose of study treatment up to 20 weeks
|
4.9%
3/61 • From first dose of study treatment up to 20 weeks
|
|
Nervous system disorders
Headache
|
13.1%
8/61 • From first dose of study treatment up to 20 weeks
|
4.8%
3/63 • From first dose of study treatment up to 20 weeks
|
4.8%
3/62 • From first dose of study treatment up to 20 weeks
|
12.1%
7/58 • From first dose of study treatment up to 20 weeks
|
6.6%
4/61 • From first dose of study treatment up to 20 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
3.2%
2/63 • From first dose of study treatment up to 20 weeks
|
0.00%
0/62 • From first dose of study treatment up to 20 weeks
|
5.2%
3/58 • From first dose of study treatment up to 20 weeks
|
1.6%
1/61 • From first dose of study treatment up to 20 weeks
|
Additional Information
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