Trial Outcomes & Findings for A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT (NCT NCT04193436)
NCT ID: NCT04193436
Last Updated: 2024-02-16
Results Overview
AUCinf was defined as area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Results posted on
2024-02-16
Participant Flow
A total of 34 participants were screened, of whom 11 had screen failure and 23 entered the study. There were 6, 6, 6 and 5 participants in the without hepatic impairment group, mild hepatic impairment group, moderate hepatic impairment group and severe hepatic impairment group, respectively. All of the 23 treated participants received their assigned treatment, and no participant discontinued.
Participant milestones
| Measure |
Without Hepatic Impairment
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
Baseline characteristics by cohort
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Between 18 and 64 years (inclusive)
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Customized
≥65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
AUCinf was defined as area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919
|
14090 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
13090 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36
|
18930 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
19630 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
Cmax was defined as maximum plasma concentration of PF-06835919 and observed directly from data.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-06835919
|
1310 ng/mL
Geometric Coefficient of Variation 17
|
1143 ng/mL
Geometric Coefficient of Variation 47
|
1340 ng/mL
Geometric Coefficient of Variation 28
|
1098 ng/mL
Geometric Coefficient of Variation 31
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
AUCinf,u was defined as unbound area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919
|
612.6 ng*hr/mL
Geometric Coefficient of Variation 29
|
746.2 ng*hr/mL
Geometric Coefficient of Variation 22
|
1093 ng*hr/mL
Geometric Coefficient of Variation 43
|
1199 ng*hr/mL
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
Cmax,u was defined as unbound maximum plasma concentration.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919
|
56.93 ng/mL
Geometric Coefficient of Variation 18
|
65.16 ng/mL
Geometric Coefficient of Variation 32
|
77.45 ng/mL
Geometric Coefficient of Variation 26
|
67.10 ng/mL
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
The fraction of PF-06835919 unbound in plasma (fu) was determined at approximately the expected Tmax in each participant.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Fraction of Drug Unbound (fu) of PF-06835919
|
0.04345 ratio
Geometric Coefficient of Variation 5
|
0.05704 ratio
Geometric Coefficient of Variation 21
|
0.05780 ratio
Geometric Coefficient of Variation 18
|
0.06111 ratio
Geometric Coefficient of Variation 14
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to follow-up (Day 31)Population: The safety analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
An 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. Treatment-emergent AE (TEAE) was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events (AEs)
With treatment-related TEAE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (AEs)
With all-causality TEAE
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (AEs)
With SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 6Population: The safety analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
To determine if there were any clinically significant laboratory abnormalities, hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular hemoglobin, mean corpuscular volume, platelet count, lymphocytes, neutrophils, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio), clinical chemistry (bilirubin, direct and indirect bilirubin, gamma glutamyl transferase, albumin, urea nitrogen, glucose) and urinalysis (glucose, protein, hemoglobin, urobilinogen, nitrite) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Lymphocytes (10^3/mm3) <0.8*LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Direct Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Prothrombin Time (sec) >1.1*ULN
|
0 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Hemoglobin (g/dL) <0.8*lower limit of normal (LLN)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Hematocrit (%) <0.8*LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Erythrocytes (10^6/mm3) <0.8*LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Ery. Mean Corpuscular Volume (um^3) >1.1*upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Platelets (10^3/mm3) <0.8*LLN
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Neutrophils (10^3/mm3) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Activated Partial Thromboplastin Time (sec) >1.1*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Prothrombin Intl. Normalized Ratio >1.1*ULN
|
0 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Indirect Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Gamma Glutamyl Transferase (U/L) >3.0*ULN
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Albumin (g/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Urea Nitrogen (mg/dL) >1.3*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Glucose (mg/dL) >1.5*ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
URINE Glucose (mg/dL) ≥1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
URINE Protein (mg/dL) ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
URINE Hemoglobin ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Urobilinogen (EU/dL) ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Nitrite ≥1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 6Population: The safety analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
ECG endpoints (PR interval, QRS interval, QT interval and QTcF) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. PR max. ≥300ms, %Chg ≥25/50%; 3. QRS max. ≥140ms，%Chg ≥50%; 3.maximum post-dose QTcF 450 - ≤480msec, 480 - ≤500msec and \>500msec, 30\<Chg≤60 and Chg\>60.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 Participants
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
PR Interval Value ≥300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
PR Interval %Chg ≥25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
QRS Interval Value ≥140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
QRS Interval %Chg ≥50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
QT Interval Value >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
QTcF (msec) 450< Value ≤480
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
QTcF (msec) 480< Value ≤500
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
QTcF (msec) Value >500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
QTcF (msec) 30< Chg ≤60
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
QTcF (msec) Chg >60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Without Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Without Hepatic Impairment
n=6 participants at risk
This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Mild Hepatic Impairment
n=6 participants at risk
This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Moderate Hepatic Impairment
n=6 participants at risk
This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
Severe Hepatic Impairment
n=5 participants at risk
This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/5 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/5 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/5 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
16.7%
1/6 • Number of events 1 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/5 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
0.00%
0/6 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
|
20.0%
1/5 • Number of events 1 • Baseline (Day 1) up to follow-up (Day 31)
All participants randomly assigned to investigational product and who took at least 1 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