Trial Outcomes & Findings for Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants (NCT NCT04427917)
NCT ID: NCT04427917
Last Updated: 2022-07-21
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
COMPLETED
PHASE1
8 participants
Baseline (Day 1) to follow-up (Day 42)
2022-07-21
Participant Flow
All participants were screened within 28 days of the first dose of study intervention. Eligible participants were admitted to the Clinical Research Unit.
A total of 8 healthy participants were enrolled in this study. Participants were randomized to 2 groups to receive PF-06835919 or placebo treatment with a randomization ratio of 3:1.
Participant milestones
| Measure |
Placebo Daily (QD)
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
|
Overall Study
COMPLETED
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants
Baseline characteristics by cohort
| Measure |
PF-06835919 300 mg Daily (QD)
n=6 Participants
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
Placebo Daily (QD)
n=2 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to follow-up (Day 42)Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Outcome measures
| Measure |
Placebo Daily (QD)
n=2 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
n=6 Participants
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study
Participants with serious adverse events
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study
Participants discontinued from study due to adverse events
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study
Participants with adverse events
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 10Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
To determine if there were any clinically significant laboratory abnormalities, haematological (hemoglobin, hematocrit, red blood cell count, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes), clinical chemistry (blood urea nitrogen, glucose \[fasting\], calcium, sodium, potassium, chloride, bicarbonate, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein) and urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.
Outcome measures
| Measure |
Placebo Daily (QD)
n=2 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
n=6 Participants
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Number of Participants With Clinical Laboratory Findings of Potential Clinical Importance
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 10Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
ECG endpoints (QTcF, PR and QRS) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1.maximum post-dose QTcF ≤450msec, 450 - ≤480msec, 480 - ≤500msec and \>500msec; 2. PR max. ≥300ms; 3. QRS max. ≥140ms.
Outcome measures
| Measure |
Placebo Daily (QD)
n=2 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
n=6 Participants
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Number of Participants With ECG Data of Potential Clinical Concern
PR Interval Value ≥ 300 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data of Potential Clinical Concern
QRS Duration Value ≥140 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data of Potential Clinical Concern
QTcF Interval Value ≤450 msec
|
2 Participants
|
6 Participants
|
|
Number of Participants With ECG Data of Potential Clinical Concern
450 msec<QTcF Interval Value ≤480 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data of Potential Clinical Concern
480 msec<QTcF Interval Value ≤500 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECG Data of Potential Clinical Concern
QTcF Interval Value >500 msec
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Study Day 1 up tp Study Day 10Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Single supine blood pressure and pulse measurements meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. Systolic Blood Pressure (BP) min. \<90mm Hg; 2. Diastolic BP min. \<50mm Hg; 3. Supine pulse rate min. \<40 bpm, max. \>120 bpm.
Outcome measures
| Measure |
Placebo Daily (QD)
n=2 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
n=6 Participants
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern
Systolic BP < 90mm Hg
|
0 Participants
|
0 Participants
|
|
Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern
Diastolic BP < 50mm Hg
|
0 Participants
|
0 Participants
|
|
Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern
Supine Pulse Rate<40bpm or >120bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern
Standing pulse rate<40bpm or >140bpm
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7Population: All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.
Cmax was defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Placebo Daily (QD)
n=6 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Summary of Maximum Plasma Concentration (Cmax) of PF-06835919 on Day 1 and Day 7
Day 1
|
23.39 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 14
|
—
|
|
Summary of Maximum Plasma Concentration (Cmax) of PF-06835919 on Day 1 and Day 7
Day 7
|
30.49 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 10
|
—
|
PRIMARY outcome
Timeframe: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7Population: All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.
AUCtau was defined as area under the plasma concentration-time curve over dosing interval.
Outcome measures
| Measure |
Placebo Daily (QD)
n=6 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Summary of Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of PF-06835919 on Day 1 and Day 7
Day 1
|
169.3 mcg*hr/mL
Geometric Coefficient of Variation 22
|
—
|
|
Summary of Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of PF-06835919 on Day 1 and Day 7
Day 7
|
230.9 mcg*hr/mL
Geometric Coefficient of Variation 20
|
—
|
PRIMARY outcome
Timeframe: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7Population: All participants who received at least 1 dose of PF-06835919 and who had at least 1 of the PK parameters of interest calculated.
Tmax was defined as Time for maximum observed concentration of PF-06835919.
Outcome measures
| Measure |
Placebo Daily (QD)
n=6 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Summary of Time for Maximum Observed Concentration (Tmax) of PF-06835919 on Day 1 and Day 7
Day 1: Tmax
|
0.834 hours
Interval 0.5 to 2.0
|
—
|
|
Summary of Time for Maximum Observed Concentration (Tmax) of PF-06835919 on Day 1 and Day 7
Day 7: Tmax
|
0.750 hours
Interval 0.5 to 1.08
|
—
|
PRIMARY outcome
Timeframe: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 7Population: All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.
t1/2 was defined as terminal half-life.
Outcome measures
| Measure |
Placebo Daily (QD)
n=6 Participants
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Summary of Terminal Half-life (t1/2) of PF-06835919 on Day 7
|
14.62 hours
Standard Deviation 2.944
|
—
|
Adverse Events
Placebo Daily (QD)
PF-06835919 300 mg Daily (QD)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Daily (QD)
n=2 participants at risk
Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
PF-06835919 300 mg Daily (QD)
n=6 participants at risk
Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/2 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
16.7%
1/6 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/2 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
16.7%
1/6 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Investigations
Weight increased
|
0.00%
0/2 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
16.7%
1/6 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
16.7%
1/6 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
16.7%
1/6 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/2 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
16.7%
1/6 • From Study Day 1 up to Study Day 42
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
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