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

Healthy Females Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608241
• Other study ID #: B7981018
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2018
• Est. completion date: November 23, 2018

Study information

• Verified date: April 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 23, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Females

Intervention

Drug:
• PF-06651600
200 mg by mouth (PO) Once daily (QD) for 11 days
• Ethinyl estradiol (EE) and levonogestrel (LN)
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN

Locations

Country	Name	City	State
United States	Quotient Sciences	Coral Gables	Florida
United States	Quotient Sciences-Miami, Inc.	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	0 (pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Secondary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		Baseline (Day 0) up to 28 days after last dose of study drug
Secondary	Number of Adverse Events by Severity		Baseline up to 28 days after last dose
Secondary	Number of Participants With Categorical Vital Signs Data		Baseline through study completion, approximately 23 days.
Secondary	Number of Participants With Change From Baseline in Laboratory Tests Results		Baseline through study completion, approximately 23 days.

External Links

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