This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06835919 in healthy adult Japanese participants. A total of approximately 8 healthy participants will be enrolled in this study. Participants will be randomized to 2 groups to receive PF-06835919 or placebo treatment with a randomization ratio of 3:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
8
PF-06835919 300 mg repeated doses
Placebo repeated doses
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région de, Belgium
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study
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.
Time frame: Baseline (Day 1) to follow-up (Day 42)
Number of Participants With Clinical Laboratory Findings of Potential Clinical Importance
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.
Time frame: Day 1 to Day 10
Number of Participants With ECG Data of Potential Clinical Concern
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.
Time frame: Day 1 to Day 10
Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern
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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.
Time frame: From Study Day 1 up tp Study Day 10
Summary of Maximum Plasma Concentration (Cmax) of PF-06835919 on Day 1 and Day 7
Cmax was defined as maximum observed plasma concentration.
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7
Summary of Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of PF-06835919 on Day 1 and Day 7
AUCtau was defined as area under the plasma concentration-time curve over dosing interval.
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7
Summary of Time for Maximum Observed Concentration (Tmax) of PF-06835919 on Day 1 and Day 7
Tmax was defined as Time for maximum observed concentration of PF-06835919.
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7
Summary of Terminal Half-life (t1/2) of PF-06835919 on Day 7
t1/2 was defined as terminal half-life.
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 7