Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus (NCT NCT04889157)
NCT ID: NCT04889157
Last Updated: 2024-10-01
Results Overview
AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
Results posted on
2024-10-01
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56.
|
PF-06882961 BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|
|
BLINDED TREATMENT
STARTED
|
5
|
15
|
|
BLINDED TREATMENT
Discontinued
|
0
|
0
|
|
BLINDED TREATMENT
COMPLETED
|
5
|
15
|
|
BLINDED TREATMENT
NOT COMPLETED
|
0
|
0
|
|
Follow-Up
STARTED
|
5
|
15
|
|
Follow-Up
Received Treatment
|
5
|
15
|
|
Follow-Up
COMPLETED
|
5
|
15
|
|
Follow-Up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56.
|
PF-06882961 BID
n=15 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Mean (SD)
|
50 Years
STANDARD_DEVIATION 4.64 • n=5 Participants
|
49.5 Years
STANDARD_DEVIATION 7.22 • n=7 Participants
|
49.6 Years
STANDARD_DEVIATION 6.56 • n=5 Participants
|
|
Age, Customized
20-44 Years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
45-60 Years
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1Population: All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.
AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.
Outcome measures
| Measure |
PF-06882961 10 mg Single Dose
n=15 Participants
Participants received single dose of PF-06882961 on Day 1.
|
PF-06882961 BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
PF-06882961 120 mg BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1
|
287.4 nanogram*hour per milliter (ng*hr/mL)
Geometric Coefficient of Variation 52
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1Population: All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.
Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.
Outcome measures
| Measure |
PF-06882961 10 mg Single Dose
n=15 Participants
Participants received single dose of PF-06882961 on Day 1.
|
PF-06882961 BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
PF-06882961 120 mg BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1
|
37.37 nanogram per milliter (ng/mL)
Geometric Coefficient of Variation 39
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)Population: All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.
AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Outcome measures
| Measure |
PF-06882961 10 mg Single Dose
n=15 Participants
Participants received single dose of PF-06882961 on Day 1.
|
PF-06882961 BID
n=15 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
PF-06882961 120 mg BID
n=14 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|---|
|
AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
|
1446 ng*hr/mL
Geometric Coefficient of Variation 236
|
1012 ng*hr/mL
Geometric Coefficient of Variation 1414
|
984.9 ng*hr/mL
Geometric Coefficient of Variation 2327
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)Population: All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.
Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Outcome measures
| Measure |
PF-06882961 10 mg Single Dose
n=15 Participants
Participants received single dose of PF-06882961 on Day 1.
|
PF-06882961 BID
n=15 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
PF-06882961 120 mg BID
n=14 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|---|
|
Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
|
150.3 ng/mL
Geometric Coefficient of Variation 176
|
98.92 ng/mL
Geometric Coefficient of Variation 1059
|
110.5 ng/mL
Geometric Coefficient of Variation 3069
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose (Day 70)Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest and maximum absolute values and maximum changes from baseline from time-matched baseline were evaluated at the investigator's discretion.
Outcome measures
| Measure |
PF-06882961 10 mg Single Dose
n=5 Participants
Participants received single dose of PF-06882961 on Day 1.
|
PF-06882961 BID
n=15 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
PF-06882961 120 mg BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Supine systolic blood pressure (mmHg) change >=30 mm Hg decrease
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Supine systolic blood pressure (mmHg) change >=30 mm Hg increase
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Supine diastolic blood pressure (mmHg) change >=20 mm Hg increase
|
1 Participants
|
6 Participants
|
—
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Supine diastolic blood pressure (mmHg) change >=20 mm Hg decrease
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Supine pulse rate (beats per minute [bpm]) value >120 bpm
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose (Day 70)Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.
Outcome measures
| Measure |
PF-06882961 10 mg Single Dose
n=5 Participants
Participants received single dose of PF-06882961 on Day 1.
|
PF-06882961 BID
n=15 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
PF-06882961 120 mg BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG)
PR interval not otherwise specified (msec) %change >=50%
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiogram (ECG)
QTcF not otherwise specified (msec) 450 < Value <=480
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 35 days after last dose (Day 91)Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Outcome measures
| Measure |
PF-06882961 10 mg Single Dose
n=5 Participants
Participants received single dose of PF-06882961 on Day 1.
|
PF-06882961 BID
n=15 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
PF-06882961 120 mg BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Participants with non-serious AEs
|
5 Participants
|
14 Participants
|
—
|
|
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Participants with serious adverse events
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose (Day 70)Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Laboratory tests (including hematological, clinical chemistry, urinalysis tests) were reported and abnormality was determined at the investigator's discretion.
Outcome measures
| Measure |
PF-06882961 10 mg Single Dose
n=5 Participants
Participants received single dose of PF-06882961 on Day 1.
|
PF-06882961 BID
n=15 Participants
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
PF-06882961 120 mg BID
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
Hematology - Neutrophils (10^3/mm3) >1.2xupper limit of norma (ULN)
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Hematology - Basophils (10^3/mm3) >1.2xULN
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Chemistry - Urate (mg/dL) >1.2xULN
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Chemistry - high-density lipoprotein cholesterol (mg/dL) <0.8xlower limit of normal (LLN)
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Chemistry - Triglycerides (mg/dL) >1.3xULN
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Chemistry - Thyrotropin (uIU/mL) <0.8xLLN
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Chemistry - Bile Acid (umol/L) >1.0xULN
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis - Urine Glucose ≥1
|
3 Participants
|
6 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis - Urine Ketones (Scalar) ≥1
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis - Urine Protein ≥1
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis - Urine Hemoglobin (Scalar) ≥1
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis - Urine Urobilinogen ≥1
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis - Urine Nitrite (Scalar) ≥1
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis - Urine Leukocyte Esterase (Scalar) ≥1
|
0 Participants
|
2 Participants
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06882961 BID
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=5 participants at risk
Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56.
|
PF-06882961 BID
n=15 participants at risk
Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • Baseline up to 35 days after last dose (Day 91)
|
0.00%
0/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • Baseline up to 35 days after last dose (Day 91)
|
13.3%
2/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Eye disorders
Photophobia
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
13.3%
2/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
3/5 • Baseline up to 35 days after last dose (Day 91)
|
80.0%
12/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Baseline up to 35 days after last dose (Day 91)
|
80.0%
12/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
13.3%
2/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Baseline up to 35 days after last dose (Day 91)
|
80.0%
12/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
2/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Investigations
Blood pressure increased
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
13.3%
2/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Investigations
Blood uric acid increased
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
13.3%
2/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Investigations
Hepatic enzyme increased
|
20.0%
1/5 • Baseline up to 35 days after last dose (Day 91)
|
0.00%
0/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Baseline up to 35 days after last dose (Day 91)
|
60.0%
9/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Baseline up to 35 days after last dose (Day 91)
|
13.3%
2/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Baseline up to 35 days after last dose (Day 91)
|
26.7%
4/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Nervous system disorders
Sleep deficit
|
20.0%
1/5 • Baseline up to 35 days after last dose (Day 91)
|
0.00%
0/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Baseline up to 35 days after last dose (Day 91)
|
6.7%
1/15 • Baseline up to 35 days after last dose (Day 91)
|
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