This is a Phase 1, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
400 mg by mouth (PO) Once daily (QD) for 11 days
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Qps-Mra, Llc
South Miami, Florida, United States
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for EE was determined using linear/Log trapezoidal method.
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration for Levonorgestrel
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for LN was determined using linear/Log trapezoidal method.
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Maximum Plasma Concentration (Cmax) for Ethinyl Estradiol
Cmax was defined as maximum plasma concentration. Cmax for EE was observed directly from data.
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Maximum Plasma Concentration for Levonorgestrel
Cmas was defined as maximum plasma concentration. Cmax for LN was observed directly from data.
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Number of Participants With Treatment Emergent Treatment-Related Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study 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 intervention in a participant who received study intervention. Treatment-emergent are events between first dose of study intervention and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
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Time frame: From the first dose up to 35 days after the last dose of study intervention
Number of Participants With Treatment Emergent Adverse Events by Severity
An AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. AEs are classified according to the severity in 3 categories. a) mild - AEs does not interfere with participant's usual function; b) moderate - AEs interferes to some extent with participant's usual function; c) severe - AEs interferes significantly with participant's usual function. Only those categories in which at least 1 participant had data were reported.
Time frame: From the first dose up to 35 days after the last dose of study intervention
Number of Participants With Categorical Vital Signs Data of Potential Clinical Concern
Systolic blood pressure (BP), diastolic BP and supine pulse rate measurements meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: Systolic BP min. \<90 mmHg; Systolic BP max. decrease ≥30 or max. increase ≥30; Diastolic BP min. \<50 mmHg; Diastolic BP max. decrease ≥20 or max. increase ≥20; Supine pulse rate min. \<40 bpm or max. \>120 bpm.
Time frame: Day 1 for Period 1 and Day 1, Day 10, Day 12 for Period 2
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern
Hematology (hemoglobin, hematocrit, erythrocytes \[Ery.\], Ery.mean corpuscular volume, Ery.mean corpuscular hemoglobin, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); clinical chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase); and urinalysis (pH, glucose, ketones, protein, hemoglobin, urobilinogen, bilirubin, nitrite, leukocyte esterase, Ery., leukocytes, epithelial cells, casts and bacteria) tests were assessed. Only those categories, in which at least 1 participant had data were reported.
Time frame: Day 10, Day 12 for Period 2