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OpenTrials
Completed

NCT Number: NCT04018274

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

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Screening Office, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

  • 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 -

Treatment and study plan

PF-06651600

Drug

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

Ethinyl estradiol (EE) and levonorgestrel(LN)

Drug

Oral tablet containing 30 ug EE and 150 ug of LN

Other names: Oral contraceptives

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, OPEN LABEL, 2 WAY CROSSOVER STUDY TO DEMONSTRATE A LACK OF AN EFFECT OF MULTIPLE DOSE PF 06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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