Trial Outcomes & Findings for A Study To Assess the Effects Of PF-04457845 On BOLD fMRI In Subjects With Post Traumatic Stress Disorder (NCT NCT02216097)
NCT ID: NCT02216097
Last Updated: 2016-06-29
Results Overview
Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.
TERMINATED
PHASE2
14 participants
Baseline, Day 8
2016-06-29
Participant Flow
Participant milestones
| Measure |
PF-04457845
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
|
Placebo
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study To Assess the Effects Of PF-04457845 On BOLD fMRI In Subjects With Post Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
PF-04457845
n=8 Participants
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
|
Placebo
n=6 Participants
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.6 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
36.2 Years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
35.9 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to Good Clinical Practice (GCP) non-compliance that resulted in data integrity and quality issues.
Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 2Population: There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.
Difference measured in BOLD fMRI percent activation in the bilateral vmPFC during the fear extinction recall phase of the fear extinction paradigm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 8Population: There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.
Difference measured in BOLD fMRI percent signal change in the right amygdala in fear versus neutral faces during the emotional face processing task.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 8Population: There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.
Difference measured in BOLD fMRI percent signal change in the left amygdala in fearful versus neutral faces during face processing task.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to Day 18Population: The safety analysis population included all participants who received study medication.
The full physical examination included head, ears, eyes, nose, mouth, skin, heart, and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.
Outcome measures
| Measure |
PF-04457845
n=8 Participants
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
|
Placebo
n=6 Participants
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
|
|---|---|---|
|
Number of Participants With Abnormal Physical Examination Findings
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last study drug administration (Day 35)Population: The safety analysis population included all participants who received 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 28 days after last study drug administration that were absent before treatment or that worsened relative to pretreatment state. AEs included non-serious AEs and SAEs.
Outcome measures
| Measure |
PF-04457845
n=8 Participants
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
|
Placebo
n=6 Participants
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
Number of Participants with AEs
|
6 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
Number of Participants with SAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
Number of Participants Discontinued Due to AEs
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 18Population: The safety analysis population included all participants who received study medication.
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); chemistry (glucose); urinalysis (dipstick) (urine pH, urine glucose, urine protein, urine blood, urine ketones, urine bilirubin, urine nitrite, urine leukocyte esterase); urinalysis microscopy (urine red blood cell, urine white blood cell, urine bacteria). Only parameters with abnormal values were reported.
Outcome measures
| Measure |
PF-04457845
n=8 Participants
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
|
Placebo
n=6 Participants
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
|
|---|---|---|
|
Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern
Total neutrophils <0.8 times lower limit of normal
|
1 participants
|
0 participants
|
|
Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern
Urine positive for nitrite
|
1 participants
|
0 participants
|
|
Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern
Urine positive for leukocyte esterase
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 18Population: The safety analysis population included all participants who received study medication.
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate \<40 or \>120 beats per minute (bpm), standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) of \>=30 millimeters of mercury (mmHg) change from baseline or SBP \<90 mmHg; diastolic blood pressure (DBP) \>=20 mmHg change from baseline or DBP \<50 mmHg.
Outcome measures
| Measure |
PF-04457845
n=8 Participants
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
|
Placebo
n=6 Participants
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
|
|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine SBP <90 mmHg
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Standing SBP <90 mmHg
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine DBP <50 mmHg
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Standing DBP <50 mmHg
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine Pulse Rate <40 or >120 bpm
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Standing Pulse Rate <40 or >140 bpm
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine SBP >=30 mmHg Increase From Baseline
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Standing SBP >=30 mmHg Increase From Baseline
|
0 participants
|
1 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine DBP >=20 mmHg Increase From Baseline
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Standing DBP >=20 mmHg Increase From Baseline
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine SBP >=30 mmHg Decrease From Baseline
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Standing SBP >=30 mmHg Decrease From Baseline
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine DBP >=20 mmHg Decrease From Baseline
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Standing DBP >=20 mmHg Decrease From Baseline
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 18Population: The safety analysis population included all participants who received study medication.
ECG criteria of potential clinical concern were QTc absolute value \>=450 milliseconds (msec) or QTc absolute change \>=30 msec.
Outcome measures
| Measure |
PF-04457845
n=8 Participants
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
|
Placebo
n=6 Participants
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
|
|---|---|---|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern
QTcF Interval 450-<480 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern
QTcF Interval 480-<500 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern
QTcF Interval >=500 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern
QTcF Interval >=30 msec Increase From Baseline
|
0 participants
|
0 participants
|
Adverse Events
PF-04457845
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-04457845
n=8 participants at risk
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
|
Placebo
n=6 participants at risk
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 3
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
50.0%
4/8 • Number of events 4
|
50.0%
3/6 • Number of events 3
|
|
Nervous system disorders
Migraine
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Affect lability
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Flashback
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: 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