Clincosm LogoSign in Get a demo

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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04018274
Collaborator
(none)
29
Enrollment
2
Locations
2
Arms
2.2
Actual Duration (Months)
14.5
Patients Per Site
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Aug 9, 2019
Actual Primary Completion Date :
Oct 16, 2019
Actual Study Completion Date :
Oct 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence 1

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

Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)
Oral tablet containing 30 ug EE and 150 ug of LN
Other Names:
  • Oral contraceptives

    		•
    Experimental: Sequence 2

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

    Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)
    Oral tablet containing 30 ug EE and 150 ug of LN
    Other Names:
  • Oral contraceptives

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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).

    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quotient Sciences Screening Office Coral Gables Florida United States 33134
    2 Quotient Sciences, Miami Miami Florida United States 33126

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04018274
    Other Study ID Numbers:
    • B7981035
    First Posted:
    Jul 12, 2019
    Last Update Posted:
    Nov 15, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Levonorgestrel
    Ethinyl Estradiol
    Contraceptive Agents
    Contraceptives, Oral
    Estradiol

    Study Results

    No Results Posted as of Nov 15, 2019