Phase 1
Completed N=10
A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
Healthy
Source: ClinicalTrials.gov NCT05064332 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol — 812.3; 823.9 picogram*hour per milliliter (pg*hr/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol |
812.3; 823.9 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration for Levonorgestrel |
31510; 34190 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for Ethinyl Estradiol |
84.00; 79.86 | — |
| PRIMARY Maximum Plasma Concentration for Levonorgestrel |
3468; 4092 | — |
| SECONDARY Number of Participants With Treatment Emergent Treatment-Related Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events by Severity |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Categorical Vital Signs Data of Potential Clinical Concern |
0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities of Potential Clinical Concern |
5; 2 | — |
Eligibility Criteria
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:
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure.
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:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing
- Benign ethnic (cyclic) neutropenia.
Data sourced from ClinicalTrials.gov (NCT05064332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.