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A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Quotient Sciences
Coral Gables, Florida, 33134 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Females
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
the study:

1. Healthy female subjects of non childbearing potential

Female subjects of non childbearing potential must meet at least 1 of the following
criteria:

1. 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;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including
female subjects with tubal ligations) are considered to be of childbearing
potential and are not eligible for this study.

2. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Subjects with any of the following characteristics/conditions will not be included in the
study:

1. 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).

2. History of drug abuse with less than 6 months of abstinence prior to the baseline
visit.

3. History of regular alcohol consumption exceeding 7 drinks/week for female subjects (1
drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL]
of hard liquor) within 6 months before screening.

4. Any medical reason which would contraindicate the administration of oral
contraceptives (as per the label) or history of discontinued use of oral
contraceptives due to medical reasons.

5. Subjects with a known immunodeficiency disorder or a first degree relative with a
hereditary immunodeficiency.

6. Subjects who have a malignancy or a history of malignancy, with the exception of
adequately treated or excised non metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.

7. Any current evidence of untreated active or latent or inadequately treated infection
with Mycobacterium tuberculosis (TB).

8. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing

NCT03608241
Pfizer
Recruiting
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Phase 1, Randomized, Open Label, 2-way Crossover Study To Estimate The Effect Of Multiple Dose Pf-06651600 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids In Healthy Female Subjects
This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description:
Open label

Primary Purpose: Basic Science

Healthy Females
  • Drug: PF-06651600
    200 mg by mouth (PO) Once daily (QD) for 11 days
  • Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
    Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
    Other Name: Oral contraceptive
  • Experimental: Treatment sequence 1
    Treatment sequence 1 will receive a single dose of an oral contraceptive during the first period of the study (period 1) and then continue to the second period (Period 2) of the study where they will receive PF-06651600 every day for 11 days and a single dose of an oral contraceptive towards the end of the period.
    Interventions:
    • Drug: PF-06651600
    • Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
  • Experimental: Treatment Sequence 2
    Treatment sequence 2 will receive PF-06651600 every day for 11 days during the first period of the study (period 1) and a single dose of an oral contraceptive towards the end of this period. After completion of Period 1, there will be a washout period of at least 10 days before starting the second period of the study (period 2). During period 2, a single dose of an oral contraceptive will be received.
    Interventions:
    • Drug: PF-06651600
    • Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
Same as current
November 1, 2018
October 6, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

  1. Healthy female subjects of non childbearing potential

    Female subjects of non childbearing potential must meet at least 1 of the following criteria:

    1. 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;
    2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    3. Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential and are not eligible for this study.
  2. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

Subjects with any of the following characteristics/conditions will not be included in the study:

  1. 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).
  2. History of drug abuse with less than 6 months of abstinence prior to the baseline visit.
  3. History of regular alcohol consumption exceeding 7 drinks/week for female subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
  4. Any medical reason which would contraindicate the administration of oral contraceptives (as per the label) or history of discontinued use of oral contraceptives due to medical reasons.
  5. Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
  6. Subjects who have a malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  7. Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
  8. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Healthy female subjects of non childbearing potential
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03608241
B7981018
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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