A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)

NCT05064332 | Completed Phase 1 Results FDA Drug

• 1 other identifier: B7921026
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events

  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

  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

  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

  Day 10, Day 12 for Period 2

Study Arms (2)

OC only

EXPERIMENTAL

Subjects will receive a single dose of an oral contraceptive during the first period of the study

Drug: Ethinyl estradiol (EE) and levonogestrel (LN)

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.

Drug: PF-06650833; Drug: Ethinyl estradiol (EE) and levonogestrel (LN)

Interventions

PF-06650833 DRUG

400 mg by mouth (PO) Once daily (QD) for 11 days

PF-06650833 + OC

Ethinyl estradiol (EE) and levonogestrel (LN) DRUG

Single dose of Oral tablet containing 30 ug EE and 150 ug of LN

Also known as: Oral contraceptive (OC)

OC only; PF-06650833 + OC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide; Ethinyl Estradiol; Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: October 8, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: October 2, 2023
• Results First Posted: October 2, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)