A Phase 1 interventional study of PF-06650833 and Ethinyl estradiol (EE) and levonogestrel (LN) in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
Female subjects of non childbearing potential must meet at least 1 of the following criteria:
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential and will be eligible with adequate contraceptive usage.
Exclusion Criteria:
Subjects with any of the following characteristics/conditions will not be included in the study:
Subjects will receive a single dose of an oral contraceptive during the first period of the study
Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
Subjects will receive PF-06650833 every day for 11 days and a single dose of an oral contraceptive on day 10.
Drug: PF-06650833 · Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
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
Also known as: Oral contraceptive (OC)
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.
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
Participants were screened 28 days prior to the first dose of study intervention in Period 1 and reported to the clinical research unit the day prior to Day 1 dosing in Period 1.
| Milestone | Oral Contraceptive (OC) Then PF-06650833+ OC |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
| Milestone | Oral Contraceptive (OC) Then PF-06650833+ OC |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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.
| picogram*hour per milliliter (pg*hr/mL) | Period 1: Oral Contraceptive | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol | 812.3 ± 25 | 823.9 ± 26 |
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.
| pg*hr/mL | Period 1: Oral Contraceptive | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration for Levonorgestrel | 31510 ± 39 | 34190 ± 41 |
Cmax was defined as maximum plasma concentration. Cmax for EE was observed directly from data.
| picogram per milliliter (pg/mL) | Period 1: Oral Contraceptive | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for Ethinyl Estradiol | 84.00 ± 38 | 79.86 ± 26 |
Cmas was defined as maximum plasma concentration. Cmax for LN was observed directly from data.
| pg/mL | Period 1: Oral Contraceptive | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|---|
| Maximum Plasma Concentration for Levonorgestrel | 3468 ± 56 | 4092 ± 53 |
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.
| Participants | Period 1: Oral Contraceptive | Period 2: PF-06650833 | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|---|---|
| Treatment-related AEs | 0 | 0 | 0 |
| Treatment-related SAEs | 0 | 0 | 0 |
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.
| Participants | Period 1: Oral Contraceptive | Period 2: PF-06650833 | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|---|---|
| Nausea (mild) | 0 | 1 | 0 |
| Toothache (mild) | 0 | 0 | 1 |
| Headache (mild) | 0 | 1 | 0 |
| Pruritus (mild) | 0 | 2 | 0 |
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.
| Participants | Period 1: Oral Contraceptive | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|---|
| Number of Participants With Categorical Vital Signs Data of Potential Clinical Concern | 0 | 0 |
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.
| Participants | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|
| Urine Hemoglobin ≥1 | 5 |
| Leukocyte Esterase ≥1 | 2 |
Collected over From the first dose up to 35 days after the last dose of study intervention.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1: Oral Contraceptive | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Period 2: PF-06650833 | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) |
| Period 2: PF-06650833 + Oral Contraceptive | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Event | Period 1: Oral Contraceptive | Period 2: PF-06650833 | Period 2: PF-06650833 + Oral Contraceptive |
|---|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 0/10 | 2/10 | 0/10 |
| NauseaGastrointestinal disorders | 0/10 | 1/10 | 0/10 |
| ToothacheGastrointestinal disorders | 0/10 | 0/10 | 1/10 |
| HeadacheNervous system disorders | 0/10 | 1/10 | 0/10 |
The baseline analysis population defined as all participants enrolled to study intervention and who took at least 1 dose of study intervention.
| Age, Categorical(Participants) | OC Then PF-06650833+ OC |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | OC Then PF-06650833+ OC |
|---|---|
| Female | 10 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | OC Then PF-06650833+ OC |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | OC Then PF-06650833+ OC |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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