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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC only | Experimental | Subjects will receive a single dose of an oral contraceptive during the first period of the study |
|
| PF-06650833 + OC | Experimental | Subjects will receive PF-06650833 every day for 11 days and a single dose of an oral contraceptive on day 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06650833 | Drug | 400 mg by mouth (PO) Once daily (QD) for 11 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
Healthy female subjects
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.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria:
Subjects with any of the following characteristics/conditions will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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The study consisted of 2 periods in a single fixed sequence. Period 1 was immediately followed by Period 2 with no washout. A total of 10 participants were enrolled in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Contraceptive (OC) Then PF-06650833+ OC | Participants received a single oral dose of OC, containing ethinyl estradiol (EE) 30 microgram (mcg) and levonorgestrel (LN) 150 mcg on Day 1 Period 1. After completion of Period 1, participants orally received PF-06650833 400 milligram (mg) once daily (QD) on Days 1-11 of Period 2 and a single oral dose of OC, containing EE 30 mcg and LN 150 mcg on Day 10 Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
The baseline analysis population defined as all participants enrolled to study intervention and who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | OC Then PF-06650833+ OC | Participants received a single oral dose of OC, containing EE 30 mcg and LN 150 mcg on Day 1 Period 1. After completion of Period 1, participants orally received PF-06650833 400 mg QD on Days 1-11 of Period 2 and a single oral dose of OC, containing of EE 30 mcg and LN 150 mcg on Day 10 Period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The PK parameter analysis population was defined as all participants that received at least 1 dose of study intervention and had at least 1 of the PK parameters of primary interest reported in at least 1 period. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram*hour per milliliter (pg*hr/mL) | Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2 |
|
From the first dose up to 35 days after the last dose of study intervention.
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: Oral Contraceptive | Participants received a single oral dose of OC, containing EE 30 mcg and LN 150 mcg on Day 1 Period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2021 | Nov 30, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2021 | Nov 30, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000621967 | 1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide |
| D004997 | Ethinyl Estradiol |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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| Ethinyl estradiol (EE) and levonogestrel (LN) |
| Drug |
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN |
|
|
| 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. | 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. | 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. | Day 10, Day 12 for Period 2 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Period 2: PF-06650833 + Oral Contraceptive | Participants orally received PF-06650833 400 mg QD on Days 1-11 of Period 2 and a single oral dose of OC, containing of EE 30 mcg and LN 150 mcg on Day 10 Period 2. |
|
|
|
| Primary | 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. | The PK parameter analysis population was defined as all participants that received at least 1 dose of study intervention and had at least 1 of the PK parameters of primary interest reported in at least 1 period. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*hr/mL | Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2 |
|
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) for Ethinyl Estradiol | Cmax was defined as maximum plasma concentration. Cmax for EE was observed directly from data. | The PK parameter analysis population was defined as all participants that received at least 1 dose of study intervention and had at least 1 of the PK parameters of primary interest reported in at least 1 period. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram per milliliter (pg/mL) | Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2 |
|
|
|
|
| Primary | Maximum Plasma Concentration for Levonorgestrel | Cmas was defined as maximum plasma concentration. Cmax for LN was observed directly from data. | The PK parameter analysis population was defined as all participants that received at least 1 dose of study intervention and had at least 1 of the PK parameters of primary interest reported in at least 1 period. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2 |
|
|
|
|
| Secondary | 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. | The safety analysis set was defined as all participants enrolled to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From the first dose up to 35 days after the last dose of study intervention |
|
|
|
| Secondary | 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. | The safety analysis set was defined as all participants enrolled to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From the first dose up to 35 days after the last dose of study intervention |
|
|
|
| Secondary | 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. | The safety analysis set was defined as all participants enrolled to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 for Period 1 and Day 1, Day 10, Day 12 for Period 2 |
|
|
|
| Secondary | 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. | The safety analysis set was defined as all participants enrolled to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 10, Day 12 for Period 2 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Period 2: PF-06650833 | Participants orally received PF-06650833 400 mg QD on Days 1-10 of Period 2. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG002 | Period 2: PF-06650833 + Oral Contraceptive | Participants received a single oral dose of OC, containing of EE 30 mcg and LN 150 mcg on Day 10 Period 2 and a single oral dose of PF-06650833 400 mg on Day 11 Period 2. | 0 | 10 | 0 | 10 | 1 | 10 |
| Toothache | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 24.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | Non-systematic Assessment |
|
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.
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
|
| Title | Measurements |
|---|---|
|
| Headache (mild) |
|
| Pruritus (mild) |
|