Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids

NCT04018274 | Completed Phase 1 FDA Drug

• 1 other identifier: B7981035
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 06651600 on single-dose oral contraceptive (OC) pharmacokinetics (PK) in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 28 healthy female subjects (14 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE

  30 micrograms administered as oral OC combination tablet

  predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN

  150 micrograms administered as oral OC combination tablet

  predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2

Study Arms (2)

Sequence 1

EXPERIMENTAL

In Treatment Sequence 1, period 1, participants will be dosed with a single administration of oral contraceptive (OC). Participants will continue directly into Period 2 where they will receive PF-06651600 PO for 9 days followed by administration of a single dose of OC on the morning of Day 10.

Drug: PF-06651600; Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)

Sequence 2

EXPERIMENTAL

In Treatment Sequence 2, Period 1, participants will be dosed with PF-06651600 PO QD for 9 days and administered a single dose of OC on the morning of Day 10. After a washout period of at least 10 days, participants will continue into Period 2 and will receive an additional single dose of OC.

Drug: PF-06651600; Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)

Interventions

PF-06651600 DRUG

50 mg by mouth (PO) once daily (QD)

Sequence 1; Sequence 2

Ethinyl estradiol (EE) and levonorgestrel(LN) DRUG

Oral tablet containing 30 ug EE and 150 ug of LN

Also known as: Oral contraceptives

Sequence 1; Sequence 2

Eligibility Criteria

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

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Age and Sex:
• Female participants of non childbearing potential who, at the time of screening, are between the ages of 18 and 60 years, inclusive.
• Female participants who are healthy as determined by medical evaluation including detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lb).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
• Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first-degree relative with a hereditary immunodeficiency.
• Infection with hepatitis B or hepatitis C viruses -

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Quotient Sciences Screening Office

Coral Gables, Florida, 33134, United States

Location

Quotient Sciences, Miami

Miami, Florida, 33126, United States

Location

Related Links

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

MeSH Terms

Interventions

PF-06651600; Ethinyl Estradiol; Levonorgestrel; 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; Norgestrel; Norpregnenes; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 12, 2019
• Study Start: August 9, 2019
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)