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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06651600; Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)

• Registration Number: NCT04018274
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Study Start: 2019-08-09
• Primary Completion: 2019-10-16
• Study Completion: 2019-10-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Age and Sex:

1. Female participants of non childbearing potential who, at the time of screening, are between the ages of 18 and 60 years, inclusive.
2. 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.
3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
4. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

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Exclusion Criteria

1. 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).
2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
3. Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first-degree relative with a hereditary immunodeficiency.
4. Infection with hepatitis B or hepatitis C viruses -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Ethinyl estradiol (EE) and levonorgestrel(LN)	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.
Sequence 1	PF-06651600	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.
Sequence 1	Ethinyl estradiol (EE) and levonorgestrel(LN)	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.
Sequence 2	PF-06651600	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE	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	30 micrograms administered as oral OC combination tablet
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN	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	150 micrograms administered as oral OC combination tablet

Trial Locations

Locations (2)

Quotient Sciences Screening Office; 🇺🇸 Coral Gables, Florida, United States

Quotient Sciences, Miami; 🇺🇸 Miami, Florida, United States